NCT04105764

Deep NMB in Ambulatory Gynecological Laparoscopy

Deep Neuromuscular Blockade to Improve Postoperative Quality of Recovery in Ambulatory Gynaecologic Laparoscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Wahba bakhet · Academic / Other
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Gynecological laparoscopic surgery is commonly performed as an ambulatory basis for the aim of rapid discharge, reduce hospital stay with reduced costs and to improve postoperative QOR \[1,2\]. However, the creation of pneumoperitoneum during laparoscopy may cause postoperative pain and other physiological changes \[3\], which could influence the postoperative QOR negatively \[4\]. Poor postoperative QOR leads to prolonged hospital stay \[5\].

Detailed description

Deep NMB is known to improve surgical conditions and pneumoperitoneium related complications in laparoscopic surgery \[6,7,8,9\]. However, it is unknown whether deep NMB improves postoperative QOR in ambulatory gynecological laparoscopy. Therefore, we designed a double blind randomised trial to compare the effects of deep and moderate NMB on postoperative QOR in ambulatory gynecological laparoscopic surgery. We hypothesized that deep NMB improves postoperative QOR, compared to moderate NMB. The primary outcome was postoperative QOR in POD1. The secondary outcome was quality of surgical conditions, pain scores, time to meet PACU and hospital discharge, and opioid consumption

Conditions

• Muscle Relaxation

Interventions

Type	Name	Description
DRUG	Rocuronium	DEEP block to PTC 1-3
DRUG	Rocuronium bromide	MODERATE block to TOF1-2

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-11-01
• Completion: 2019-06-15
• First posted: 2019-09-26
• Last updated: 2019-12-10

Locations

1 site across 1 country: Kuwait