Intermittent manually controlled versus continuous infusion of propofol for deep sedation during interventional endoscopy: A prospective randomized trial

Abstract

Introduction. Beside the traditional, intermittent bolus application of propofol, continuous propofol infusion via infusion pump is an alternative procedure for deep sedation during long-lasting interventional endoscopy. However, up to now, there are no randomized comparisons for gastrointestinal endoscopy. Methods. One hundred patients (ERCP: n = 60, EUS: n = 40) were randomly assigned to receive intermittent bolus application (“bolus group”) or continuous infusion (“perfusor group”) of propofol sedation after induction with 3 mg midazolam for deep sedation. Patients in the bolus group received an initial propofol dose according to body weight (bw <70 kg: 40 mg; bw ≥70 kg 60 mg). In the perfusor group, bw-adapted, continuous propofol infusion (6 mg/kg) via the Injectomat 2000 MC (Fresenius-Kabi) was administered after an initial bolus of 1 mg/kg. Vital signs, dose of propofol, patient cooperation (VAS 1–10), sedation depth, and the recovery time as well as the quality of recovery were evaluated. Results. Total propofol dose in the bolus group 305 ± 155 mg (100–570 mg) and in the perfusor group 343 ± 123 mg (126–590 mg, p = 0.5) were comparable. Oxygen saturation below 90% was seen in four patients of each group, with no need for assisted ventilation. Arterial blood pressure <90 mmHg was documented in two patients in the bolus group and seven patients in the perfusor group (p = 0.16). Patients' cooperation was rated as good in both groups (bolus group, 9.1 ± 0.9; perfusor group, 8.9 ± 1; p = 0.17). Recovery time was significantly shorter in the bolus group compared with the perfusor group (19 ± 5 versus 23 ± 6 min, p < 0.001) whereas the quality of recovery was nearly identical in both groups. Conclusion. Both sedation regimens allow nearly identical good controllability of propofol sedation. However, recovery time was significantly slower and hypotension was tended to occur more often in the perfusor group.

Key Words::

• continuous propofol infusion
• gastrointestinal endoscopy
• intermittent propofol sedation
• propofol
• sedation

Acknowledgement

Andrea Riphaus: study design, electronic data-base creation and management, data collection, drafting of the article. Christoph Geist: electronic data base management, writing of the paper. Kerstin Schrader: data collection. Ksenia Martchenko: data collection. Till Wehrmann: study design, statistical analysis, and drafting of the article.

Declaration of interest: A. Riphaus has received speaker fees from Fresenius-Kabi, Nycomed, Falk Foundation, and Astra Zeneca and research support from Fresenius-Kabi and Oridion. T. Wehrmann has received speaker fees from Fresenius-Kabi, Falk Foundation, B. Braun-Melsungen, and Nycomed, and research support from Fresenius-Kabi, Olympus, B. Braun-Melsungen, and Paion. Fresenius-Kabi, Bad Homburg, Germany, provided the Injectomat 2000 MC but did not participate in study design, data collection, data analysis, or manuscript preparation.