A comparison of intravenous lorazepam and diazepam as endoscopic premedications
J.
J.
Ramirez-Acosta, V. Whizar-Lugo, C. Cruz-Lozano, Elizondo-Rivera,
MD MD MD MD
Mexico City, Mexico
Intravenous lorazepam was compared to diazepam as premedication for gastrointestinal endoscopy in 40 consecutive patients during a double-blind trial. For the doses given, patients receiving lorazepam were more often drowsy or asleep during the procedure than those who received diazepam. Twenty-four hours later at least 50% of the lorazepam patients failed to remember a series of events which occurred on the day of their endoscopy as opposed to 20% of the diazepam patients. Lorazepam is a safe and effective premedicant for gastrointestinal endoscopy; it renders a tranquil patient who is largely unaware of events which occur during the procedure.
Pharmacological preparations are generally administered to patients scheduled for gastrointestinal endoscopy to induce relaxation, to diminish the gag reflex, and to depress muscular spasms without significant antiperistaltic effects. Although a wide variety of premedications are available, the benzodiazepine derivatives have generally given good results.' This double-blind study demonstrates the safety and efficacy of lorazepam, a new benzodiazepine (currently available in the US as Ativan only in an oral dosage form), as a premedicating agent for gastrointestinal endoscopy. Diazepam (Valium) was used as a standard for comparison. METHODS The 40 adults who participated in this doubleblind trial were randomized into 2 groups of 20 patients. At least 30 minutes before the start of the endoscopic examination, patients received an intravenous injection of either lorazepam (0.05 mg/kg) or diazepam (10 mg) in addition to intramuscular atropine (0.5 mg). The 10 mg dose of diazepam was chosen because it is the standard dose used by most endoscopists in our area. No other concomitant medications were administered. Degree of sedation was rated for each patient using a scale which ranged from 1 (awake and agitated) to 6 (asleep and cannot be awakened). The reactions (cooperation, relaxation,
calmness) and responses (at the introduction of the endoscope, during and following the procedure) as well as overall patient acceptance were rated on scales which ranged from 1 (poor) to 4 (excellent). Vital signs were monitored during the procedure; all adverse reactions were recorded. Patients were interviewed 24 hours after the procedure and asked to remember 4 events which each of them had experienced: entering the endoscopy room, the introduction of the endoscope as well as its withdrawal, and having been shown a memory card (an enlarged picture of a Mexican 100 peso note) while in the endoscopy room. RESULTS Codes were broken after the fortieth endoscopic examination had been completed; statistical analysis showed that the lorazepam and diazepam groups were homogenous with respect to age, weight, and sex. Table I shows the degree of sedation for each patient who received lorazepam or diazepam; none was judged "drowsy but agitated" or "asleep cannot be awakened". An analysis of the 4 remaining categories showed that the lorazepam group was significantly more sedated than the diazepam group. The responses and reactions of each group are given in Table II. Mean scores are shown for each of the 7 measures rated in addition to the number of points accumulated over all
From the Departments of Anaesthesia and Acute Medicine and Endoscopy, Instituto Nacional de la Nutrici6n, Ave. San Fernando y Viaducto de Tlalpan, Mexico 22, D.F., Mexico.
80
GASTROINTESTINAL ENDOSCOPY
+ Fisher's Exact Test • Denotes statistical significance.
Ten patients who received lorazepam (50%) compared to 4 who received diazepam (20%) failed to recall the introduction of the endoscope; this difference is only marginally significant. The lack of recall of the memory card was statistically equivalent for both groups; 15 patients in the lorazepam group (75%) and 12 in the diazepam group (60%) could not remember it. An equivalent number of drug related reactions occurred with both medications. One lorazepam patient experienced dizziness and another had prolonged drowsi ness, complained of headache and tiredness as well as burning at the injection site (after 24 hours). One diazepam patient had tearing and emesis after the medication, another felt dizzy, and a third experienced immediate post-injection stinging. The vital signs of patients in both groups remained stable following the administration of the test medications. DISCUSSION Diazepam has been used frequently as a premedicating agent for endoscopy;2- 4 10razepam, a much newer drug, has been used to only a limited extent. Trials with oral lorazepam S- 7 have shown excellent patient sedation without cardiopulmonary depression; in addition, many of the patients tested were unable to recall the endoscopic procedure. The present study illustrates that intravenous lorazepam is as safe and effective for gastrointestinal endoscopy as diazepam. The gag-reflex was adequately diminished in both groups, patients relaxed during the examination, belching and nausea were kept to a minimum, and recuperation from the procedure was rapid. However, with the doses given, patients who received lorazepam were more sedated than those who received diazepam, and many were asleep or drowsy during the endoscopy, whereas the bulk of the diazepam group was awake (although calm) during the procedure. In addition, at least half of the lorazepam group could not recall the "traumatic" events connected with the procedure (the endoscopy room, the insertion and withdrawal of the instrument), whereas only 20% of the diazepam patients failed to remember these events. A similar trend was shown with the memory card, although lack of recall was quite high (75% lorazepam, 60% diazepam) for both groups. Either lorazepam or diazepam wi II rei ieve the apprehension or restlessness of patients about to undergo endoscopy. Lorazepam, however, renders a more tranquil patient who is largely unaware of events which occur during the procedure. Lorazepam is an entirely satisfactory premedicating agent and an excellent choice for the successfu I performance of gastroi ntestinal endoscopy.
the items (minimum score 7 points, maximum score 28 points). Many patients had ratingsthat were good to excellent; for example, the scores of 11 subjects in the lorazepam group and 8 in the diazepam group totalled 26 to 28 poi nts. Although the analysis showed that each' mean score as well as the total score of patients who receivedlor
J.
J.
Ramirez-Acosta, V. Whizar-Lugo, C. Cruz-Lozano, Elizondo-Rivera,
MD MD MD MD
Mexico City, Mexico
Intravenous lorazepam was compared to diazepam as premedication for gastrointestinal endoscopy in 40 consecutive patients during a double-blind trial. For the doses given, patients receiving lorazepam were more often drowsy or asleep during the procedure than those who received diazepam. Twenty-four hours later at least 50% of the lorazepam patients failed to remember a series of events which occurred on the day of their endoscopy as opposed to 20% of the diazepam patients. Lorazepam is a safe and effective premedicant for gastrointestinal endoscopy; it renders a tranquil patient who is largely unaware of events which occur during the procedure.
Pharmacological preparations are generally administered to patients scheduled for gastrointestinal endoscopy to induce relaxation, to diminish the gag reflex, and to depress muscular spasms without significant antiperistaltic effects. Although a wide variety of premedications are available, the benzodiazepine derivatives have generally given good results.' This double-blind study demonstrates the safety and efficacy of lorazepam, a new benzodiazepine (currently available in the US as Ativan only in an oral dosage form), as a premedicating agent for gastrointestinal endoscopy. Diazepam (Valium) was used as a standard for comparison. METHODS The 40 adults who participated in this doubleblind trial were randomized into 2 groups of 20 patients. At least 30 minutes before the start of the endoscopic examination, patients received an intravenous injection of either lorazepam (0.05 mg/kg) or diazepam (10 mg) in addition to intramuscular atropine (0.5 mg). The 10 mg dose of diazepam was chosen because it is the standard dose used by most endoscopists in our area. No other concomitant medications were administered. Degree of sedation was rated for each patient using a scale which ranged from 1 (awake and agitated) to 6 (asleep and cannot be awakened). The reactions (cooperation, relaxation,
calmness) and responses (at the introduction of the endoscope, during and following the procedure) as well as overall patient acceptance were rated on scales which ranged from 1 (poor) to 4 (excellent). Vital signs were monitored during the procedure; all adverse reactions were recorded. Patients were interviewed 24 hours after the procedure and asked to remember 4 events which each of them had experienced: entering the endoscopy room, the introduction of the endoscope as well as its withdrawal, and having been shown a memory card (an enlarged picture of a Mexican 100 peso note) while in the endoscopy room. RESULTS Codes were broken after the fortieth endoscopic examination had been completed; statistical analysis showed that the lorazepam and diazepam groups were homogenous with respect to age, weight, and sex. Table I shows the degree of sedation for each patient who received lorazepam or diazepam; none was judged "drowsy but agitated" or "asleep cannot be awakened". An analysis of the 4 remaining categories showed that the lorazepam group was significantly more sedated than the diazepam group. The responses and reactions of each group are given in Table II. Mean scores are shown for each of the 7 measures rated in addition to the number of points accumulated over all
From the Departments of Anaesthesia and Acute Medicine and Endoscopy, Instituto Nacional de la Nutrici6n, Ave. San Fernando y Viaducto de Tlalpan, Mexico 22, D.F., Mexico.
80
GASTROINTESTINAL ENDOSCOPY
+ Fisher's Exact Test • Denotes statistical significance.
Ten patients who received lorazepam (50%) compared to 4 who received diazepam (20%) failed to recall the introduction of the endoscope; this difference is only marginally significant. The lack of recall of the memory card was statistically equivalent for both groups; 15 patients in the lorazepam group (75%) and 12 in the diazepam group (60%) could not remember it. An equivalent number of drug related reactions occurred with both medications. One lorazepam patient experienced dizziness and another had prolonged drowsi ness, complained of headache and tiredness as well as burning at the injection site (after 24 hours). One diazepam patient had tearing and emesis after the medication, another felt dizzy, and a third experienced immediate post-injection stinging. The vital signs of patients in both groups remained stable following the administration of the test medications. DISCUSSION Diazepam has been used frequently as a premedicating agent for endoscopy;2- 4 10razepam, a much newer drug, has been used to only a limited extent. Trials with oral lorazepam S- 7 have shown excellent patient sedation without cardiopulmonary depression; in addition, many of the patients tested were unable to recall the endoscopic procedure. The present study illustrates that intravenous lorazepam is as safe and effective for gastrointestinal endoscopy as diazepam. The gag-reflex was adequately diminished in both groups, patients relaxed during the examination, belching and nausea were kept to a minimum, and recuperation from the procedure was rapid. However, with the doses given, patients who received lorazepam were more sedated than those who received diazepam, and many were asleep or drowsy during the endoscopy, whereas the bulk of the diazepam group was awake (although calm) during the procedure. In addition, at least half of the lorazepam group could not recall the "traumatic" events connected with the procedure (the endoscopy room, the insertion and withdrawal of the instrument), whereas only 20% of the diazepam patients failed to remember these events. A similar trend was shown with the memory card, although lack of recall was quite high (75% lorazepam, 60% diazepam) for both groups. Either lorazepam or diazepam wi II rei ieve the apprehension or restlessness of patients about to undergo endoscopy. Lorazepam, however, renders a more tranquil patient who is largely unaware of events which occur during the procedure. Lorazepam is an entirely satisfactory premedicating agent and an excellent choice for the successfu I performance of gastroi ntestinal endoscopy.
the items (minimum score 7 points, maximum score 28 points). Many patients had ratingsthat were good to excellent; for example, the scores of 11 subjects in the lorazepam group and 8 in the diazepam group totalled 26 to 28 poi nts. Although the analysis showed that each' mean score as well as the total score of patients who receivedlor
