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Clinical Trials/NCT06469866
NCT06469866
Recruiting
Not Applicable

Effect of Deep Neuromuscular Block on the Quality of Recovery After Laparoscopic Hysterectomy

Anqing Municipal Hospital1 site in 1 country72 target enrollmentJune 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuromuscular Blockade
Sponsor
Anqing Municipal Hospital
Enrollment
72
Locations
1
Primary Endpoint
Quality of recovery
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

BACKGROUND: Some studies have revealed that deep neuromuscular block (NMB) improve surgical conditions and alleviated postoperative pain compared with moderate NMB. The present study investigated deep NMB could improve the quality of recovery after laparoscopic hysterectomy

METHODS: seventy-two women with elective laparoscopic hysterectomy were randomly divided into 2 groups: Patients in group A received low-pressure pneumoperitoneum (LPP), which was set at 8-10 mmHg with deep NMB. Patients in group B received standard-pressure pneumoperitoneum (SPP), which was set at 12-14 mmHg with moderate NMB. Primary outcome was the quality of recovery (QoR-15) at 1 day after sugery. The secondary outcomes included postoperative pain, surgical condition, incidence of shoulder pain, the incidence of rescue analgesic drug use, cumulative dose of analgesics, time of first flatus, post-operative nausea and vomiting, time of tracheal tube removal.

Registry
clinicaltrials.gov
Start Date
June 25, 2024
End Date
November 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅲ
  • Scheduled for elective laparoscopic hysterectomy

Exclusion Criteria

  • Inability to give informed consent
  • Renal or hepatic insufficiency
  • History of preoperative psychiatric
  • Previous surgery at procedure site
  • Neuromuscular disease, pregnancy, and contraindications to study medications.

Outcomes

Primary Outcomes

Quality of recovery

Time Frame: 1 day after operation

Primary outcome measure was the quality of recovery at 1 day after surgery. Quality of recovery-15 scale was used to assess the quality of recovery after operation. A higher score of quality of recovery-15 scale indicates a better quality of recovery after surgery

Secondary Outcomes

  • Postoperative nausea and vomiting(The first 24 hours after operation)
  • Shoulder pain(The first 24 hours after operation)

Study Sites (1)

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