Safe and effective sedation in endoscopic submucosal dissection for early gastric cancer: a randomized comparison between propofol continuous infusion and intermittent midazolam injection.
OBJECTIVE
Endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) generally takes longer to perform than conventional endoscopy and usually requires moderate/deep sedation with close surveillance for patient safety. The aim of this study was to compare the safety profiles and recovery scores propofol continuous infusion and intermittent midazolam (MDZ) injection as sedation for ESD.


METHODS
Sixty EGC patients scheduled for ESDs between August and November 2008 were included in this prospective study and randomly divided into a propofol (P-group, 28 patients) and an MDZ (M-group, 32 patients) group using an odd-even system. The P-group received a 0.8 mg/kg induction dose and a 3 mg/kg/h maintenance dose of 1% propofol using an infusion pump. All patients received 15 mg pentazocine at the start of the ESD and at 60-min intervals thereafter. We recorded and analyzed blood pressure, oxygen saturation and heart rate during and following the procedure and evaluated post-anesthetic recovery scores (PARS) and subsequent alertness scores.


RESULTS
The propofol maintenance and total dose amounts were (mean +/- standard deviation) 3.7 +/- 0.6 mg/kg/h and 395 +/- 202 mg, respectively. The mean total dose of MDZ was 10.3 +/- 4.5 mg. There were no cases of de-saturation <90% or hypotension <80 mmHg in either group. Alertness scores 15 and 60 min after the procedures were significantly higher in the P-group (4.9/4.9) than in the M-group (4.6/4.5; p < 0.05). The mean PARS 15 and 30 min after the ESDs were significantly higher in the P-group (9.6/9.9) than in the M-group (8.6/9.2; p < 0.01).


CONCLUSIONS
Based on our results, the ESDs for EGC performed under sedation using propofol continuous infusion were as safe as those performed using intermittent MDZ injection. Propofol-treated patients had a quicker recovery profile than those treated with MDZ. We therefore recommend the use of continuous propofol sedation for ESD, but sedation guidelines for the use of propofol are necessary.
Department of Endoscopy, National Cancer Center Hospital, Tokyo, Japan. drkiriyama@yahoo.co.jp
Shinsuke
S
Kiriyama
Takuji
T
Gotoda
Hiromi
H
Sano
Ichiro
I
Oda
Fumiya
F
Nishimoto
Tetsuro
T
Hirashima
Chika
C
Kusano
Hiroyuki
H
Kuwano
D000368:Aged; D000369:Aged, 80 and over; D000762:Anesthesia Recovery Period; D018686:Anesthetics, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016292:Procedural Sedation / Q000009:adverse effects / Q000379:methods; D054810:Deep Sedation / Q000009:adverse effects / Q000379:methods; D004334:Drug Administration Schedule; D004724:Endoscopy / Q000379:methods*; D005260:Female; D005753:Gastric Mucosa / Q000473:pathology / Q000601:surgery; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007262:Infusions, Intravenous; D008297:Male; D008874:Midazolam / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D015742:Propofol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000601:surgery*
D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives; D008874:Midazolam; D015742:Propofol