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Completed

NCT Number: NCT04105764

Deep NMB in Ambulatory Gynecological Laparoscopy

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].

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Key information

Conditions

Muscle Relaxation

Age range

21 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Elite Medical Center

Kuwait City, 002, Kuwait

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I and II

Exclusion criteria

  • Neuromuscular disorders

Treatment and study plan

Rocuronium

Drug

DEEP block to PTC 1-3

Other names: Neuromuscular blocker

Rocuronium bromide

Drug

MODERATE block to TOF1-2

Other names: Neuromuscular blocker

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Wahba bakhet

Other

Collaborators

  • Elite medical center

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 26, 2019
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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