Digestive Endoscopy 2014; 26: 417–423
doi: 10.1111/den.12189
Original Article
Effect of midazolam on cardiopulmonary function during colonoscopy with conscious sedation Young Hoon Kim,1 Ji Won Kim,1 Kook Lae Lee,1 Sae Kyung Joo,1 Jaekyung Lee,1 Seong-Joon Koh,1 Byeong Gwan Kim1 and Chan-Kuk Park2 1
Department of Internal Medicine, Seoul National University Boramae Hospital, Seoul National University College of Medicine, Seoul and 2Department of Internal Medicine, Graduate School of Chosun University, Gwangju, South Korea Background and Aim: Conscious sedation of patients with
Results: In the midazolam group, SBP and DBP decreased more
midazolam reduces anxiety and pain and improves colonoscopy success rates. However, it may lead to adverse effects such as hypoxia and hypotension. The present study investigated the effects of midazolam on cardiopulmonary function during colonoscopy with conscious sedation.
during colonoscopy than in the control group. However, the frequency of a significant change in SBP was similar in both groups. During colonoscopy, HR and SpO2 decreased significantly in the midazolam group compared to those in the control group. SpO2 levels returned to normal after the procedure.
Methods: Between January 2011 and September 2011, 126 consecutive patients undergoing colonoscopy were enrolled and divided into two groups: (i) sedation with midazolam (midazolam group, n = 65); and (ii) no sedation (control group, n = 61). Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and peripheral oxygen saturation (SpO2), were recorded before, during and after the endoscopic procedure.
Conclusions: Midazolam induced decreases in SBP, DBP, HR and SpO2 during colonoscopy. Clinically significant changes in SBP, HR, and SpO2, however, were similar in the midazolam and control groups. These results suggest that midazolam has a tolerable effect on cardiopulmonary function and may be safely used during colonoscopy.
INTRODUCTION
The majority of patients can be sufficiently sedated for colonoscopy with a combination of a benzodiazepine and an opioid.4–6 Midazolam is a water-soluble benzodiazepine that is characterized by a rapid onset of action and a shorter active duration than other drugs of the same class.7 Midazolam, however, should be used with caution because it can lead to hypotension and respiratory depression.8 Oversedation may induce respiratory depression and delayed recovery time, especially in elderly patients and in those suffering from severe cardiopulmonary disorder.9 Otherwise, studies have shown midazolam to be a relatively safe premedication drug for colonoscopy examination.10,11 The aim of the present study was to investigate the effects of midazolam on cardiopulmonary function during colonoscopic examination with conscious sedation.
C
OLONOSCOPY IS WIDELY used in diagnostic and therapeutic practice to assess the large intestine from the anus to the cecum. However, mesenteric stretching during colonoscopic examination puts the patient in pain, which likely elicits reflexive colonic spasm, especially in the sigmoid colon more than at the splenic or hepatic flexures. This might not be tolerated by patients who become less cooperative because of severe pain.1,2 Patient comfort during the procedure is important for successful colonoscopy; moreover, achieving and maintaining adequate levels of analgesia and sedation may also be important. The major goal of analgesia and sedation is to relieve patient pain and anxiety; this may help to facilitate complete diagnostic and therapeutic colonoscopic examination.3
bs_bs_banner
Corresponding: Ji Won Kim, Department of Internal Medicine, Seoul National University Boramae Hospital, Seoul National University College of Medicine, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul 156-707, Korea. Email: [email protected] Received 11 July 2013; accepted 12 September 2013.
Key words: cardiopulmonary function, colonoscopy, midazolam
METHODS
T
HIS PROSPECTIVE STUDY was carried out on consecutive patients undergoing colonoscopy at Seoul National University Boramae Hospital between January
© 2013 The Authors Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society
417
418
Y. H. Kim et al.
Digestive Endoscopy 2014; 26: 417–423
2011 and September 2011. Enrolled patients were divided into two groups: (i) sedation with i.v. midazolam (midazolam group); and (ii) no sedation (control group). All patients initially received 25 mg pethidine via i.m. injection. Although a few patients required additional pethidine, we did not give more pethidine. In the midazolam group, all patients received a dose of 0.04 mg/kg but no more than 5 mg midazolam i.v. Exclusion criteria included severe cardiac or pulmonary disease, colonic obstruction, colonic stricture, poor bowel preparation, chronic use of benzodiazepines or opiates, severe liver or kidney disease, psychiatric disease, pregnancy, and communication difficulties. The study protocol was approved by the institutional review board of our institution (IRB no. 06-2011-62). Written informed consent for participation in the study was obtained from all patients. The colonoscopy was carried out by two endoscopists who had participated in more than 1000 cases annually, using an Olympus CF-260 video colonoscope (Olympus Optical Co., Tokyo, Japan). Biopsies were obtained and polypectomies were carried out if indicated. Patients were continuously monitored for heart rate (HR), blood pressure (BP), and peripheral oxygen saturation (SpO2) level, which were recorded before the colonoscopy, at the time of cecal intubation, and after the procedure. Patient monitoring was maintained during the initial recovery (usually for 30 min). A serious adverse event was defined as any of the following: (i) >20 mmHg change in systolic blood pressure (SBP); (ii) >10 mmHg change in diastolic pressure (DBP); (iii) change in HR of >15 beats per min (b.p.m.); or (iv) decrease of SpO2 10 mmHg) was more frequently observed in the midazolam group than in the control group, and the difference was statistically significant (P = 0.013). One patient from the midazolam group had a significant change in peripheral oxygen saturation, which was restored to a normal state by nasal inhalation of oxygen. Colonoscopy and polypectomy have effectively reduced the incidence of colorectal cancer. However, anxiety and pain can increase procedure times, and a prolongation of the colonoscopic examination may lead to higher complication rates.3,14 Notably, insertion of the colonoscope causes mes-
© 2013 The Authors Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society
Digestive Endoscopy 2014; 26: 417–423
Midazolam on CPF during colonoscopy with CS 421
a 80 p = 0.449
140 60
120 * *
100
*
80 Baseline
DBP (mmHg)
b
Start of colonoscopy
SBP (%)
SBP (mmHg)
a 160
Cecal End of intubation colonoscopy
40
20
90 0
80
Control group
70 * 60
*
b
*
80
Midazolam group
p = 0.013
50
Heart rate (/min)
c
Start of colonoscopy
Cecal End of intubation colonoscopy
90 80
60 DBP (%)
Baseline
40
20
70 *
60
* 0 Control group
50 Baseline
Cecal End of intubation colonoscopy
c
100
30
98
25 Heart rate (%)
SpO2 (%)
d
Start of colonoscopy
96 *
94
*
92 Baseline
Start of colonoscopy
Cecal End of intubation colonoscopy
Figure 2 Changes in (a) systolic blood pressure (SBP), (b) diastolic blood pressure (DBP), (c) heart rate (HR), and (d) peripheral oxygen saturation (SpO2) throughout colonoscopy. *P < 0.05, midazolam group ( , n = 65) vs control group ( , n = 61).
enteric stretching, which results in pain and likely elicits reflexive colonic spasm. This stress and apprehension provoke the release of catecholamines, which are responsible for alterations in heart rate.15,16 Although in many countries colonoscopy is done with any sedation, safe premedication methods may be needed for patient safety and comfort. Combinations of benzodiazepines and opioid drugs provide different sedative effects depending on the dose of each drug. Low-dose midazolam (0.01–0.05 mg/kg) results in an
Midazolam group
p = 0.067
20 15 10 5 0 Control group
Midazolam group
Figure 3 Frequencies (%) of patients exhibiting clinically significant changes in (a) systolic blood pressure (SBP), (b) diastolic blood pressure (DBP), and (c) heart rate (HR) following colonoscopy.
additive effect.17 However, high-dose midazolam (0.07– 0.037 mg/kg) results in synergic sedation effects, so we reduced the midazolam dose in this study.18 A study by Ristikankare et al.10 showed oxygen desaturation in three patients in the midazolam group and in two
© 2013 The Authors Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society
422
Y. H. Kim et al.
patients in the control group during colonoscopy (no significant difference between the groups). During the premedication phase, SBP and DBP increased in the control group but not in the midazolam group. Hypertension during colonoscopy was noted in only one patient in each study group. The prevalence of hypotension during colonoscopy was more frequent among patients in the midazolam group (19%) than in the control group (7%). In terms of SpO2, there was no difference between the groups. These results are similar to those in the current paper. In our study, however, hypotension events were more frequent than in the study by Ristikankare et al. (19% vs 32.3%). A likely explanation could be in the doses of midazolam used. In the study by Ristikankare et al., patients 41–60 years of age received 0.04 mg/kg but no more than 3.5 mg; patients 61–75 years of age received 0.03 mg/kg but no more than 2.0 mg. In our study, however, all patients received 0.04 mg/kg but no more than 5.0 mg. In a study by Cinar et al.,3 oxygen desaturation occurred in only one patient in the midazolam group, and no potentially harmful drop in oxygen saturation (
doi: 10.1111/den.12189
Original Article
Effect of midazolam on cardiopulmonary function during colonoscopy with conscious sedation Young Hoon Kim,1 Ji Won Kim,1 Kook Lae Lee,1 Sae Kyung Joo,1 Jaekyung Lee,1 Seong-Joon Koh,1 Byeong Gwan Kim1 and Chan-Kuk Park2 1
Department of Internal Medicine, Seoul National University Boramae Hospital, Seoul National University College of Medicine, Seoul and 2Department of Internal Medicine, Graduate School of Chosun University, Gwangju, South Korea Background and Aim: Conscious sedation of patients with
Results: In the midazolam group, SBP and DBP decreased more
midazolam reduces anxiety and pain and improves colonoscopy success rates. However, it may lead to adverse effects such as hypoxia and hypotension. The present study investigated the effects of midazolam on cardiopulmonary function during colonoscopy with conscious sedation.
during colonoscopy than in the control group. However, the frequency of a significant change in SBP was similar in both groups. During colonoscopy, HR and SpO2 decreased significantly in the midazolam group compared to those in the control group. SpO2 levels returned to normal after the procedure.
Methods: Between January 2011 and September 2011, 126 consecutive patients undergoing colonoscopy were enrolled and divided into two groups: (i) sedation with midazolam (midazolam group, n = 65); and (ii) no sedation (control group, n = 61). Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and peripheral oxygen saturation (SpO2), were recorded before, during and after the endoscopic procedure.
Conclusions: Midazolam induced decreases in SBP, DBP, HR and SpO2 during colonoscopy. Clinically significant changes in SBP, HR, and SpO2, however, were similar in the midazolam and control groups. These results suggest that midazolam has a tolerable effect on cardiopulmonary function and may be safely used during colonoscopy.
INTRODUCTION
The majority of patients can be sufficiently sedated for colonoscopy with a combination of a benzodiazepine and an opioid.4–6 Midazolam is a water-soluble benzodiazepine that is characterized by a rapid onset of action and a shorter active duration than other drugs of the same class.7 Midazolam, however, should be used with caution because it can lead to hypotension and respiratory depression.8 Oversedation may induce respiratory depression and delayed recovery time, especially in elderly patients and in those suffering from severe cardiopulmonary disorder.9 Otherwise, studies have shown midazolam to be a relatively safe premedication drug for colonoscopy examination.10,11 The aim of the present study was to investigate the effects of midazolam on cardiopulmonary function during colonoscopic examination with conscious sedation.
C
OLONOSCOPY IS WIDELY used in diagnostic and therapeutic practice to assess the large intestine from the anus to the cecum. However, mesenteric stretching during colonoscopic examination puts the patient in pain, which likely elicits reflexive colonic spasm, especially in the sigmoid colon more than at the splenic or hepatic flexures. This might not be tolerated by patients who become less cooperative because of severe pain.1,2 Patient comfort during the procedure is important for successful colonoscopy; moreover, achieving and maintaining adequate levels of analgesia and sedation may also be important. The major goal of analgesia and sedation is to relieve patient pain and anxiety; this may help to facilitate complete diagnostic and therapeutic colonoscopic examination.3
bs_bs_banner
Corresponding: Ji Won Kim, Department of Internal Medicine, Seoul National University Boramae Hospital, Seoul National University College of Medicine, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul 156-707, Korea. Email: [email protected] Received 11 July 2013; accepted 12 September 2013.
Key words: cardiopulmonary function, colonoscopy, midazolam
METHODS
T
HIS PROSPECTIVE STUDY was carried out on consecutive patients undergoing colonoscopy at Seoul National University Boramae Hospital between January
© 2013 The Authors Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society
417
418
Y. H. Kim et al.
Digestive Endoscopy 2014; 26: 417–423
2011 and September 2011. Enrolled patients were divided into two groups: (i) sedation with i.v. midazolam (midazolam group); and (ii) no sedation (control group). All patients initially received 25 mg pethidine via i.m. injection. Although a few patients required additional pethidine, we did not give more pethidine. In the midazolam group, all patients received a dose of 0.04 mg/kg but no more than 5 mg midazolam i.v. Exclusion criteria included severe cardiac or pulmonary disease, colonic obstruction, colonic stricture, poor bowel preparation, chronic use of benzodiazepines or opiates, severe liver or kidney disease, psychiatric disease, pregnancy, and communication difficulties. The study protocol was approved by the institutional review board of our institution (IRB no. 06-2011-62). Written informed consent for participation in the study was obtained from all patients. The colonoscopy was carried out by two endoscopists who had participated in more than 1000 cases annually, using an Olympus CF-260 video colonoscope (Olympus Optical Co., Tokyo, Japan). Biopsies were obtained and polypectomies were carried out if indicated. Patients were continuously monitored for heart rate (HR), blood pressure (BP), and peripheral oxygen saturation (SpO2) level, which were recorded before the colonoscopy, at the time of cecal intubation, and after the procedure. Patient monitoring was maintained during the initial recovery (usually for 30 min). A serious adverse event was defined as any of the following: (i) >20 mmHg change in systolic blood pressure (SBP); (ii) >10 mmHg change in diastolic pressure (DBP); (iii) change in HR of >15 beats per min (b.p.m.); or (iv) decrease of SpO2 10 mmHg) was more frequently observed in the midazolam group than in the control group, and the difference was statistically significant (P = 0.013). One patient from the midazolam group had a significant change in peripheral oxygen saturation, which was restored to a normal state by nasal inhalation of oxygen. Colonoscopy and polypectomy have effectively reduced the incidence of colorectal cancer. However, anxiety and pain can increase procedure times, and a prolongation of the colonoscopic examination may lead to higher complication rates.3,14 Notably, insertion of the colonoscope causes mes-
© 2013 The Authors Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society
Digestive Endoscopy 2014; 26: 417–423
Midazolam on CPF during colonoscopy with CS 421
a 80 p = 0.449
140 60
120 * *
100
*
80 Baseline
DBP (mmHg)
b
Start of colonoscopy
SBP (%)
SBP (mmHg)
a 160
Cecal End of intubation colonoscopy
40
20
90 0
80
Control group
70 * 60
*
b
*
80
Midazolam group
p = 0.013
50
Heart rate (/min)
c
Start of colonoscopy
Cecal End of intubation colonoscopy
90 80
60 DBP (%)
Baseline
40
20
70 *
60
* 0 Control group
50 Baseline
Cecal End of intubation colonoscopy
c
100
30
98
25 Heart rate (%)
SpO2 (%)
d
Start of colonoscopy
96 *
94
*
92 Baseline
Start of colonoscopy
Cecal End of intubation colonoscopy
Figure 2 Changes in (a) systolic blood pressure (SBP), (b) diastolic blood pressure (DBP), (c) heart rate (HR), and (d) peripheral oxygen saturation (SpO2) throughout colonoscopy. *P < 0.05, midazolam group ( , n = 65) vs control group ( , n = 61).
enteric stretching, which results in pain and likely elicits reflexive colonic spasm. This stress and apprehension provoke the release of catecholamines, which are responsible for alterations in heart rate.15,16 Although in many countries colonoscopy is done with any sedation, safe premedication methods may be needed for patient safety and comfort. Combinations of benzodiazepines and opioid drugs provide different sedative effects depending on the dose of each drug. Low-dose midazolam (0.01–0.05 mg/kg) results in an
Midazolam group
p = 0.067
20 15 10 5 0 Control group
Midazolam group
Figure 3 Frequencies (%) of patients exhibiting clinically significant changes in (a) systolic blood pressure (SBP), (b) diastolic blood pressure (DBP), and (c) heart rate (HR) following colonoscopy.
additive effect.17 However, high-dose midazolam (0.07– 0.037 mg/kg) results in synergic sedation effects, so we reduced the midazolam dose in this study.18 A study by Ristikankare et al.10 showed oxygen desaturation in three patients in the midazolam group and in two
© 2013 The Authors Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society
422
Y. H. Kim et al.
patients in the control group during colonoscopy (no significant difference between the groups). During the premedication phase, SBP and DBP increased in the control group but not in the midazolam group. Hypertension during colonoscopy was noted in only one patient in each study group. The prevalence of hypotension during colonoscopy was more frequent among patients in the midazolam group (19%) than in the control group (7%). In terms of SpO2, there was no difference between the groups. These results are similar to those in the current paper. In our study, however, hypotension events were more frequent than in the study by Ristikankare et al. (19% vs 32.3%). A likely explanation could be in the doses of midazolam used. In the study by Ristikankare et al., patients 41–60 years of age received 0.04 mg/kg but no more than 3.5 mg; patients 61–75 years of age received 0.03 mg/kg but no more than 2.0 mg. In our study, however, all patients received 0.04 mg/kg but no more than 5.0 mg. In a study by Cinar et al.,3 oxygen desaturation occurred in only one patient in the midazolam group, and no potentially harmful drop in oxygen saturation (
