Aliment. Pharmacol. Therap. (1990) 4, 423-425.

Short report : sedation for upper gastrointestinal endoscopy-diazepam versus midazolam

J. M. GILVARRY, M. CRAIG & J. F. FIELDING Department of Medicine, Beaumont Hospital, Dublin 9, Ireland Accepted for publication 14 March 1990

SUMMARY

Intravenously injected midazolam was associated with a greater degree of sedation, as assessed by 24-h retrograde amnesia, than the longer acting benzodiazepine, diazepam. No differences in the frequency of pain on injection or the occurrence of venous sequelae were noted between the two preparations. INTRODUCTION Diazepam is a lipid soluble benzodiazepine, has active metabolites and a long halflife of more than 20 h. Midazolam is water soluble, has no active metabolites and a short half-life of 1.3-2.2 h. The purpose of this study was to compare diazepam with midazolam as sedatives during upper intestinal endoscopy. The incidence of pain associated with their injection and the frequency of phlebitis associated with each preparation was also compared. PATIENTS A N D M E T H O D S

On a prospective basis, 60 consecutive patients undergoing upper intestinal endoscopy entered the study. On a stratified randomized order each patient was Correspondence to : Professor J. F. Fielding, Department of Medicine, Beaumont Hospital, Dublin 7 , Ireland. 423

424

J. M. G I L V A R R Y ef al.

Table 1. Drug efficacy and side effects Drug

Number studied Males/females Age range (mean) in years Patient immediate complaint Patient complaint at 24 h Adequate sedation Patient reaction to endoscopy Liked Disliked Neither Didn't remember Inspection of injection site at 24 h Normal Locally reddened Diffusely reddened Palpation of injection site at 24 h Non-tender Tender

Diazepam

Midazolam

30 14/16 15-73 (41.4) 0 3 27

30 13/17 20-70 (42.2) 0 I 29

2 3 6 19

0 1

2 2 7'

10 14 6

13 12

24 6

26 4

5

" P < 0.05

given 2 0 m g diazepam (in the form of Valium, Roche Products Ltd) or 1 0 m g midazolam. This dose was halved in patients over 65 years or where there was evidence of chronic lung disease. All injections were given by one of the authors (IFF) who recorded any adverse comments made by the patient during the injection. Efficacy of sedation was assessed in the short term by the acceptability of the endoscopic procedure to the patient. Twenty-four hours later, another of the authors (MC), not knowing which preparation had been given, asked the patient if he/she had any complaints regarding the procedure and whether he/she liked, disliked, neither liked or disliked, or could not remember, the endoscopy. Retrograde amnesia was taken as evidence of drug efficacy. The injection site was examined and recorded as normal, locally reddened if there was reddening at the site of injection only, or diffusely reddened if spread was greater than 3 cm. The site of injection was then palpated and recorded as non-tender or tender. Differences in results between the two groups were tested for significance by xzanalysis with the correction factor of Yates included. The appropriate ' P ' values were derived from the values obtained.

xz

RESULTS The results obtained are outlined in the table. There were no immediate complaints.

SEDATION F O R UPPER GASTROINTESTINAL E N D O S C O P Y

425

When questioned 24 h later four patients complained of inadequate sedation ;three had received diazepam and one midazolam.

DISCUSSION Adequate sedation as assessed by an experienced endoscopist was not achieved in 10% of patients who had received diazepam and in 3.3 % of those treated with midazolam. This observation is in accordance with previous studies comparing these preparati~ns.l-~ Rapid onset of sedation was observed in five patients; all had received midazolam. Retrograde amnesia for the procedure was taken as evidence of drug efficacy. This occurred significantly more frequently following administration of midazolam where 90 % of patients had no recall for the procedure as compared with 63 % of those who had received diazepam ( P < 0.05). The high degree of amnesia associated with midazolam has been reported previously and one observes a greater degree of amnesia in the more heavily sedated patients.' Other units have reported incidences of amnesia following diazepam varying from 17-54 %.4f The incidence of 63 Yo reported in this series is similar to the 67 % previously reported from this unit.6 These higher figures for diazepam may be similarly explained to the higher figures for midazolam' as higher doses were administered in the latter two studies. The incidence of painful injections and phlebitis were essentially the same in both groups. This differs from previous reports where the venous complications following the administration of midazolam were substantially This study suggests that the efficacy of intravenous midazolam as assessed by the incidence of retrograde amnesia is superior to that of intravenous diazepam. REFERENCES 1 Dundee J W, Samuel I 0,Toner W, Howard P J. Midazolam: a water soluble

benzodiazepine. Studies in volunteers. Anaesthesia 1980; 35 : 454-8. 2 Wilson D B. Amnesic action of Midazolam. Anaesthesia 1980; 35 : 459-6. 3 Gamble J A S, Kawar P, Dundee J W, Moore J, Bygs L P. Evaluation of Midazolam as an intravenous induction agent. Anaesthesia

5 Al-Khudhairi D, McCloy R D, Whitman J G. Comparison of midazolam and Diazepam in sedation for gastroscopy. Anaesthesia 1982; 37: 1002-6. 6 Craig M, Fielding J F. Drug efficacy and side effects following different formulations of intravenous diazepam. Irish J Med Sci 1982; 151: 79-80. 7 Jensen S, Huttel M S, Obeson A S. Venous

complications after i.v. administration of diazepam and midazolam. Br J Anaesth

1981; 36: 868-73. 4 Douglas J G, Nimmo W S, Wanless R, Jarvie

1981; 53: 1083-5. 8 Whitman J G, Al-Khudhairi D, McCloy R F.

D R, Heading R C, Finlayson N D C. Sedation for upper gastrointestinal endoscopy. A comparison of oral temazepam and i.v. Diazepam. Br J Anaesth 1980; 52: 811-5.

Comparison of midazolam and diazepam in doses of comparable potency during gastroscopy. Br J Anaesth 1983; 55 : 773-7.