ORIGINAL ARTICLE
PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study Debasis Banerjee, Anjan Das1, Saikat Majumdar2, Rahul Deb Mandal3, Soumyadip Dutta4, Anindya Mukherjee2, Aparna Chakraborty5, Sandip Chattopadhyay5
A B S T R A C T
Department of Anaesthesiology, MNC and H, Berhampur, West Bengal, 1 C.M.S.D.H, 2NRS Medical College, Kolkata, 3Department of G and O, Burdwan Medical College, Burdwan, 5 C.M.S.D.H, Kolkata, 4Department of Orthopedics, R.G. Kar Medical College, Kolkata, West Bengal, India Address for correspondence: Dr. Anjan Das, 174, Gorakshabashi Road, Royal Plaza Apartment (4th floor, Flat No-1), Nagerbazar, Kolkata - 28, West Bengal, India. E-mail: [email protected]
Background: postoperative nausea and vomiting (PONV) frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62) receiving (IV) Ondansetron (4 mg)] and Group B [(n=62) receiving IV Ramosetron (0.3 mg)] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P 0.05) of our patients was quite similar with other research investigations and provided us the uniform platform to evenly compare the results obtained. A study conducted by Fujii et al.[28] in a total of 100 patients yielded similar results. The mean duration of anesthesia and surgery were almost Table 1: Comparison of demographic data between the two study groups Parameter
Ondansetron (A)
Ramosetron (B)
P value
43.03±11.07 56.09±3.17 37(59.68%) : 25 (40.32%) 40/22 40 (20-99) 47 (25-106)
42.22±11.08 56.20±3.60 33(53.22%) : 29 (46.77%) 37/25 44 (24-85) 50 (29-100)
0.68 0.85 0.48
Age (years) Body weight (kg) Sex (male/ female) ASA physical status (I/II) Surgery time (min) Anesthesia time (min)
Table 2: Ambulatory surgical procedures for randomized patient groups Surgical Procedures
Again during the 18 h postoperative study period, the comparison of mean pulse rate, respiratory rate, systolic, and diastolic blood pressure showed that there was no clinically significant difference between the groups. DISCUSSION Day care surgery has proven over the years as the best method to reduce the burden on the health care resources as well as achievement of extreme patient satisfaction.[25] In developing countries like India, most of the patients avoid bearing expenses of prolonged hospital stay. At the same time the infrastructure in our country is not organized uniformly to smoothly deliver the day-care procedures. In the present day scenario, PONV still remains a big headache and nuisance for the surgeons and anesthesiologists as well as an irritating discomfort for the patients almost equal in intensity to pain.[26] The delayed convalescence, hospital readmission, delayed return to work of ambulatory patients; postoperative surgical morbidities such as pulmonary aspiration, wound dehiscence, bleeding from the wound, dehydration, electrolyte disturbances, and metabolic derangement due to excessive emetic episodes are few of the adverse consequences of the PONV.[27] Various drugs regimens and antiemetic interventions have been tried from time-to-time for the prevention of PONV but with a variable success rate. This study was carried out mainly to see the comparative efficacy of the new and much promising long acting 5-HT3 antagonist Ramosetron against Ondansetron in day-care surgery. Saudi Journal of Anesthesia
0.59 0.776 0.547
Orthopedic manipulation Surgical laparoscopy Gynecological laparoscopy Ear/nose/throat Plastic Urology Eye Burn dressing Other
Ondansetron (A) (n=62) 10(16) 20(33) 12(19) 4(6) 5(8) 0 4(6) 2(4) 5(8)
Ramosetron (B) (n=62) 12(20) 24(38) 8(12) 7(11) 4(6) 2(4) 1(1) 2(4) 2(4)
Data are n (%)
Table 3: Comparing the postoperative mean PONV episodes (in 12 h postoperative period) between the two study groups at succeeding time intervals Time after Operation (h) 0.5 1 2 4 6 12 18
PONV (episodes) Mean±SD Range Mean±SD Range Mean±SD Range Mean±SD Range Mean±SD Range Mean±SD Range Mean±SD Range
Ondansetron Ramosetron (A) (B)
P value
0.016±0.127
0.00±0.00
0.3192
0.145±0.507 0-3 0.161±0.578 0-3 0.225±0.663 0-3 0.225±0.733 0-3 0.096±0.348 0-2 0.145±0.596 0-3
0.00±0.00 0-0 0.00±0.00 0-0 0.00±0.00 0-0 0.00±0.00 0-0 0.00±0.00 0-0 0.064±0.306 0-2
0.0260 0.0299 0.0083 0.0168 0.0308 0.3455
Vol. 8, Issue 1, January-March 2014
Page | 27
Banerjee, et al.: Ramosetron for PONV in ambulatory surgery Page | 28
comparable in both the groups with no significant statistical difference [Table 1]. From Table 2 it is quite evident that types of surgical procedures were almost similar in both the groups and had no statistical significance. The incidence of PONV is very less in both the groups [Table 3] within first half hour and is not statistically significant (P > 0.05) but with passage of time Ondansetron treated A group shows signs of PONV. In all the readings 1-12 h group A (Ondansetron) patients suffered a significantly high (P < 0.05) amount of PONV in comparison with group B (Ramosetron). Again at 18th hour PONV episodes become comparable among two groups. Our results in the first 18-hour period with Ramosetron are quite comparable with many other studies[21,29-31] but comparison in a day-care setting has not been demonstrated by any literary evidence. The postoperative mean VAS scoring (in 24 h postoperative period) between the two study groups at succeeding time intervals was compared that showed no significant difference between two groups at 0.5th, 1st, 2nd, 12th, 18th h but at 4th and 6th h statistically significant difference found between Groups A and B (P < 0.05) [Table 4] suggesting that the severity of PONV was more after second hour in the case of Ondansetron than Ramosetron. Analysis of the primary outcome variable (need for rescue antiemetic metoclopramide 10 mg slow IV; Table 5) indicated that 72.58% (45 of 62) of patients receiving Ondansetron required rescue antiemetic therapy, compared with 8.06% (5 of 62) of patients receiving Ramosetron that is undoubtedly statistically significant (P < 0.05). Although the Ramosetron group was superior, Table 4: Comparing the postoperative mean VAS Scoring (in 12 h postoperative period) for severity of PONV between the two study groups at succeeding time intervals Time (h)
VAS score
4
Mean±SD Range Mean±SD Range
6
Ondansetron Ramosetron (A) (B) 0.709±1.702 0.00±0.00 0-8 0-0 1.032±2.165 0.290±0.947 0-6 0-4
P value 0.001 0.014
Results with (P
PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study Debasis Banerjee, Anjan Das1, Saikat Majumdar2, Rahul Deb Mandal3, Soumyadip Dutta4, Anindya Mukherjee2, Aparna Chakraborty5, Sandip Chattopadhyay5
A B S T R A C T
Department of Anaesthesiology, MNC and H, Berhampur, West Bengal, 1 C.M.S.D.H, 2NRS Medical College, Kolkata, 3Department of G and O, Burdwan Medical College, Burdwan, 5 C.M.S.D.H, Kolkata, 4Department of Orthopedics, R.G. Kar Medical College, Kolkata, West Bengal, India Address for correspondence: Dr. Anjan Das, 174, Gorakshabashi Road, Royal Plaza Apartment (4th floor, Flat No-1), Nagerbazar, Kolkata - 28, West Bengal, India. E-mail: [email protected]
Background: postoperative nausea and vomiting (PONV) frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62) receiving (IV) Ondansetron (4 mg)] and Group B [(n=62) receiving IV Ramosetron (0.3 mg)] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P 0.05) of our patients was quite similar with other research investigations and provided us the uniform platform to evenly compare the results obtained. A study conducted by Fujii et al.[28] in a total of 100 patients yielded similar results. The mean duration of anesthesia and surgery were almost Table 1: Comparison of demographic data between the two study groups Parameter
Ondansetron (A)
Ramosetron (B)
P value
43.03±11.07 56.09±3.17 37(59.68%) : 25 (40.32%) 40/22 40 (20-99) 47 (25-106)
42.22±11.08 56.20±3.60 33(53.22%) : 29 (46.77%) 37/25 44 (24-85) 50 (29-100)
0.68 0.85 0.48
Age (years) Body weight (kg) Sex (male/ female) ASA physical status (I/II) Surgery time (min) Anesthesia time (min)
Table 2: Ambulatory surgical procedures for randomized patient groups Surgical Procedures
Again during the 18 h postoperative study period, the comparison of mean pulse rate, respiratory rate, systolic, and diastolic blood pressure showed that there was no clinically significant difference between the groups. DISCUSSION Day care surgery has proven over the years as the best method to reduce the burden on the health care resources as well as achievement of extreme patient satisfaction.[25] In developing countries like India, most of the patients avoid bearing expenses of prolonged hospital stay. At the same time the infrastructure in our country is not organized uniformly to smoothly deliver the day-care procedures. In the present day scenario, PONV still remains a big headache and nuisance for the surgeons and anesthesiologists as well as an irritating discomfort for the patients almost equal in intensity to pain.[26] The delayed convalescence, hospital readmission, delayed return to work of ambulatory patients; postoperative surgical morbidities such as pulmonary aspiration, wound dehiscence, bleeding from the wound, dehydration, electrolyte disturbances, and metabolic derangement due to excessive emetic episodes are few of the adverse consequences of the PONV.[27] Various drugs regimens and antiemetic interventions have been tried from time-to-time for the prevention of PONV but with a variable success rate. This study was carried out mainly to see the comparative efficacy of the new and much promising long acting 5-HT3 antagonist Ramosetron against Ondansetron in day-care surgery. Saudi Journal of Anesthesia
0.59 0.776 0.547
Orthopedic manipulation Surgical laparoscopy Gynecological laparoscopy Ear/nose/throat Plastic Urology Eye Burn dressing Other
Ondansetron (A) (n=62) 10(16) 20(33) 12(19) 4(6) 5(8) 0 4(6) 2(4) 5(8)
Ramosetron (B) (n=62) 12(20) 24(38) 8(12) 7(11) 4(6) 2(4) 1(1) 2(4) 2(4)
Data are n (%)
Table 3: Comparing the postoperative mean PONV episodes (in 12 h postoperative period) between the two study groups at succeeding time intervals Time after Operation (h) 0.5 1 2 4 6 12 18
PONV (episodes) Mean±SD Range Mean±SD Range Mean±SD Range Mean±SD Range Mean±SD Range Mean±SD Range Mean±SD Range
Ondansetron Ramosetron (A) (B)
P value
0.016±0.127
0.00±0.00
0.3192
0.145±0.507 0-3 0.161±0.578 0-3 0.225±0.663 0-3 0.225±0.733 0-3 0.096±0.348 0-2 0.145±0.596 0-3
0.00±0.00 0-0 0.00±0.00 0-0 0.00±0.00 0-0 0.00±0.00 0-0 0.00±0.00 0-0 0.064±0.306 0-2
0.0260 0.0299 0.0083 0.0168 0.0308 0.3455
Vol. 8, Issue 1, January-March 2014
Page | 27
Banerjee, et al.: Ramosetron for PONV in ambulatory surgery Page | 28
comparable in both the groups with no significant statistical difference [Table 1]. From Table 2 it is quite evident that types of surgical procedures were almost similar in both the groups and had no statistical significance. The incidence of PONV is very less in both the groups [Table 3] within first half hour and is not statistically significant (P > 0.05) but with passage of time Ondansetron treated A group shows signs of PONV. In all the readings 1-12 h group A (Ondansetron) patients suffered a significantly high (P < 0.05) amount of PONV in comparison with group B (Ramosetron). Again at 18th hour PONV episodes become comparable among two groups. Our results in the first 18-hour period with Ramosetron are quite comparable with many other studies[21,29-31] but comparison in a day-care setting has not been demonstrated by any literary evidence. The postoperative mean VAS scoring (in 24 h postoperative period) between the two study groups at succeeding time intervals was compared that showed no significant difference between two groups at 0.5th, 1st, 2nd, 12th, 18th h but at 4th and 6th h statistically significant difference found between Groups A and B (P < 0.05) [Table 4] suggesting that the severity of PONV was more after second hour in the case of Ondansetron than Ramosetron. Analysis of the primary outcome variable (need for rescue antiemetic metoclopramide 10 mg slow IV; Table 5) indicated that 72.58% (45 of 62) of patients receiving Ondansetron required rescue antiemetic therapy, compared with 8.06% (5 of 62) of patients receiving Ramosetron that is undoubtedly statistically significant (P < 0.05). Although the Ramosetron group was superior, Table 4: Comparing the postoperative mean VAS Scoring (in 12 h postoperative period) for severity of PONV between the two study groups at succeeding time intervals Time (h)
VAS score
4
Mean±SD Range Mean±SD Range
6
Ondansetron Ramosetron (A) (B) 0.709±1.702 0.00±0.00 0-8 0-0 1.032±2.165 0.290±0.947 0-6 0-4
P value 0.001 0.014
Results with (P
