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Deep NMB in Ambulatory Gynecological Laparoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04105764
Recruitment Status : Completed
First Posted : September 26, 2019
Last Update Posted : December 10, 2019
Elite medical center
Information provided by (Responsible Party):
Wahba bakhet, Ain Shams University

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].

Condition or disease Intervention/treatment Phase
Muscle Relaxation Drug: Rocuronium Drug: Rocuronium bromide Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Deep Neuromuscular Blockade to Improve Postoperative Quality of Recovery in Ambulatory Gynaecologic Laparoscopy
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: DEEP BLOCK
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.
Drug: Rocuronium
DEEP block to PTC 1-3
Other Name: Neuromuscular blocker

Active Comparator: Moderate block
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.
Drug: Rocuronium bromide
MODERATE block to TOF1-2
Other Name: Neuromuscular blocker

Primary Outcome Measures :
  1. Quality of recovery [ Time Frame: 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 :
  1. Postoperative pain [ Time Frame: 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • ASA I and II

Exclusion Criteria:

  • Neuromuscular disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04105764

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Elite Medical Center
Kuwait, Kuwait, 002
Sponsors and Collaborators
Wahba bakhet
Elite medical center
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Responsible Party: Wahba bakhet, LECTRURE, Ain Shams University Identifier: NCT04105764    
Other Study ID Numbers: elite NMB
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Web
Supporting Materials: Study Protocol
Time Frame: 1 YEAR
Access Criteria: Web

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromuscular Blocking Agents
Neuromuscular Nondepolarizing Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs