Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy

Not Applicable

Recruiting

• Conditions: Laparoscopy; Neuromuscular Blockade
• Interventions: Device: low-pressure pneumoperitoneum; Device: standard-pressure pneumoperitoneum

• Registration Number: NCT06469866
• Lead Sponsor: Anqing Municipal Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24
• Study Start: 2024-06-25
• Primary Completion: 2024-11-25
• Study Completion: 2024-11-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

• Inability to give informed consent
• BMI >35
• Renal or hepatic insufficiency
• History of preoperative psychiatric
• Previous surgery at procedure site
• Neuromuscular disease, pregnancy, and contraindications to study medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery	standard-pressure pneumoperitoneum	standard-pressure pneumoperitoneum (SPP) with moderate NMB.
low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery	low-pressure pneumoperitoneum	low-pressure pneumoperitoneum (LPP) with deep NMB.
low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery	standard-pressure pneumoperitoneum	low-pressure pneumoperitoneum (LPP) with deep NMB.
standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery	low-pressure pneumoperitoneum	standard-pressure pneumoperitoneum (SPP) with moderate NMB.

Primary Outcome Measures

Name	Time	Method
Quality of recovery	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 Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting	The first 24 hours after operation	Secondary Outcome Measure was the incidence of postoperative nausea and vomiting. PONV score was evaluated verbally with a descriptive scale (0 = None, 1 = Mild Nausea, 2 = Moderate Nausea, 3 = One Vomiting, 4 = Multiple Vomiting).
Shoulder pain	The first 24 hours after operation	Secondary Outcome Measure was the incidence of shoulder pain

Trial Locations

Locations (1)

Department of Anqing Munucipal Hospital Anesthesiology; 🇨🇳 Anqing, Anhui, China