Deep NMB in Ambulatory Gynecological Laparoscopy

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04105764

Enrollment

Registered

2019-09-26

Start date

2016-12-01

Completion date

2019-06-15

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Relaxation

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

Interventions

DRUGRocuronium

DEEP block to PTC 1-3

DRUGRocuronium bromide

MODERATE block to TOF1-2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* ASA I and II

Exclusion criteria

* Neuromuscular disorders

Design outcomes

Primary

Measure	Time frame	Description
Quality of recovery	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

Measure	Time frame	Description
Postoperative pain	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)

Countries

Kuwait

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026