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Deep NMB in Ambulatory Gynecological Laparoscopy

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ClinicalTrials.gov Identifier: NCT04105764
Recruitment Status : Completed
First Posted : September 26, 2019
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Elite medical center
Information provided by (Responsible Party):
Wahba bakhet, Ain Shams University

Tracking Information
First Submitted Date  ICMJE September 25, 2019
First Posted Date  ICMJE September 26, 2019
Last Update Posted Date December 10, 2019
Actual Study Start Date  ICMJE December 1, 2016
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep NMB in Ambulatory Gynecological Laparoscopy
Official Title  ICMJE Deep Neuromuscular Blockade to Improve Postoperative Quality of Recovery in Ambulatory Gynaecologic Laparoscopy
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Muscle Relaxation
Intervention  ICMJE
  • Drug: Rocuronium
    DEEP block to PTC 1-3
    Other Name: Neuromuscular blocker
  • Drug: Rocuronium bromide
    MODERATE block to TOF1-2
    Other Name: Neuromuscular blocker
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Rocuronium
  • 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.
    Intervention: Drug: Rocuronium bromide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2019)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 15, 2019
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I and II

Exclusion Criteria:

  • Neuromuscular disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kuwait
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04105764
Other Study ID Numbers  ICMJE elite NMB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Web
Supporting Materials: Study Protocol
Time Frame: 1 YEAR
Access Criteria: Web
Responsible Party Wahba bakhet, Ain Shams University
Study Sponsor  ICMJE Wahba bakhet
Collaborators  ICMJE Elite medical center
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP