Deep NMB in Ambulatory Gynecological Laparoscopy

Phase 4

Completed

• Conditions: Muscle Relaxation
• Interventions: Drug: Rocuronium; Drug: Rocuronium bromide

• Registration Number: NCT04105764
• Lead Sponsor: Wahba bakhet

Brief 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

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2018-11-01
• Study Completion: 2019-06-15
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-07
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• ASA I and II

Exclusion Criteria

• Neuromuscular disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEEP BLOCK	Rocuronium	In the deep NMB-group, a PTC of 1 to 2 twitches was maintained, and NMB was reversed with sugammadex at the end of surgery.
Moderate block	Rocuronium bromide	In the moderate NMB group, a TOF count of 1 to 2 was maintained and NMB was reversed with a combination of neostigmine and glycopyrolate at the end of surgery.

Primary Outcome Measures

Name	Time	Method
Quality of recovery	24 hours postoperative	Quality of recovery-40 (QoR-40) questionnaire, which includes five general quality of life dimensions: physical independence (5 items), pain (7 items), .emotional state (9 items), psychological support (7 items), and physical independence (5 items). Each item was graded with a 5-point score: none of the time, some of the time,usually, most of the time and all of the time. The total score on the QoR- 40 questionnaire ranges from 40 to 200 representing, respectively, extremely poor to excellent

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	During the length of hospital stay post surgery (on average 24 hours)	Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)

Trial Locations

Locations (1)

Elite Medical Center; 🇰🇼 Kuwait, Kuwait