Satisfaction and safety using dexmedetomidine or propofol sedation during endoscopic oesophageal procedures: A randomised controlled trial

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Abstract

BACKGROUND

Dexmedetomidine possesses anxiolytic and hypnotic properties without respiratory side-effects, making it theoretically an ideal sedative agent for endoscopic procedures.

OBJECTIVE

We aimed to compare satisfaction and safety among outpatients receiving sedation with dexmedetomidine or propofol for endoscopic oesophageal procedures.

DESIGN

A randomised controlled study.

SETTING

Endoscopic intervention suite at the Academic Medical Centre in Amsterdam, Netherlands.

PARTICIPANTS

Patients aged at least 18 years, and American Society of Anesthesiologists’ physical status 1 to 3.

INTERVENTION

Total 63 patients were randomised to receive either dexmedetomidine (D) or propofol (P). Pain was treated with alfentanil in both groups.

MAIN OUTCOME MEASURES

The primary outcomes were patients’ and endoscopists’ satisfaction levels measured by validated questionnaires (1 = very dissatisfied; 7 = highly satisfied). A secondary outcome was safety, determined by blood pressure, heart rate and oxygen saturation during and after the procedure, and respiratory rate and noninvasive cardiac output during the procedure.

RESULTS

Satisfaction of patients [median (IQR); group D, 5.0 (3.75 to 5.75) vs. group P, 6.25 (5.3 to 6.5)] and satisfaction of gastroenterologists [group D, 5.0 (4.4 to 5.8) vs. group P, 6.0 (5.4 to 6.0)] were lower in group D (both P < 0.001). More patients in group D would not recommend this form of sedation to one of their friends (group D, 15 of 32 vs. group P, 1 of 31; P < 0.001). Total 30 min after the procedure, heart rate [group D, 60 bpm (52 to 69) vs. group P, 70 bpm (60 to 81), P = 0.031] and SBP group D, 112 mmHg (92 to 132) vs. group P, 120 mmHg (108 to 132); P = 0.013] were significantly lower after dexmedetomidine sedation. There were no other differences in safety between groups.

CONCLUSION

Compared with propofol, sedation with dexmedetomidine resulted in less satisfaction, and caused prolonged haemodynamic depression after endoscopic oesophageal procedures.

TRIAL REGISTRATION

ISRCTN Register (ISRCTN 68599804).

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