Deep NMB in Ambulatory Gynecological Laparoscopy

Muscle Relaxation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105764
• Other study ID #: elite NMB
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2016
• Est. completion date: June 15, 2019

Study information

• Verified date: December 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 15, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA I and II

Exclusion Criteria:

• Neuromuscular disorders

Related Conditions & MeSH terms

• Muscle Relaxation

Intervention

Drug:
• Rocuronium
DEEP block to PTC 1-3
• Rocuronium bromide
MODERATE block to TOF1-2

Locations

Country	Name	City	State
Kuwait	Elite Medical Center	Kuwait

Sponsors (2)

Lead Sponsor	Collaborator
Wahba bakhet	Elite medical center

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of recovery	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	24 hours postoperative
Secondary	Postoperative pain	Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)	During the length of hospital stay post surgery (on average 24 hours)