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Deep NMB in Ambulatory Gynecological Laparoscopy

NCT ID: NCT04105764

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-06-15

Brief Summary

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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

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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

Conditions

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Muscle Relaxation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type DRUG

DEEP block to PTC 1-3

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.

Group Type ACTIVE_COMPARATOR

Rocuronium bromide

Intervention Type DRUG

MODERATE block to TOF1-2

Interventions

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Rocuronium

DEEP block to PTC 1-3

Intervention Type DRUG

Rocuronium bromide

MODERATE block to TOF1-2

Intervention Type DRUG

Other Intervention Names

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Neuromuscular blocker Neuromuscular blocker

Eligibility Criteria

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Inclusion Criteria

* ASA I and II

Exclusion Criteria

* Neuromuscular disorders
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Elite medical center

UNKNOWN

Sponsor Role collaborator

Wahba bakhet

OTHER

Sponsor Role lead

Responsible Party

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Wahba bakhet

LECTRURE

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Elite Medical Center

Kuwait City, , Kuwait

Site Status

Countries

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Kuwait

Other Identifiers

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elite NMB

Identifier Type: -

Identifier Source: org_study_id