Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy

NCT06469866 | Recruiting

• 1 other identifier: xuzhang520
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Blockade; Laparoscopy

Keywords

Neuromuscular block; Recovery; Laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

• Quality of recovery

  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

  1 day after operation

Secondary Outcomes (2)

• Shoulder pain

  The first 24 hours after operation

• Postoperative nausea and vomiting

  The first 24 hours after operation

Study Arms (2)

low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery

EXPERIMENTAL

low-pressure pneumoperitoneum (LPP) with deep NMB.

Device: low-pressure pneumoperitoneum; Device: standard-pressure pneumoperitoneum

standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery

EXPERIMENTAL

standard-pressure pneumoperitoneum (SPP) with moderate NMB.

Device: low-pressure pneumoperitoneum; Device: standard-pressure pneumoperitoneum

Interventions

low-pressure pneumoperitoneum DEVICE

low-pressure pneumoperitoneum (LPP) with deep NMB.

low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery; standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery

standard-pressure pneumoperitoneum DEVICE

standard-pressure pneumoperitoneum (SPP) with moderate NMB.

low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery; standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anqing Municipal Hospital: lead

Study Sites (1)

Department of Anqing Munucipal Hospital Anesthesiology

Anqing, Anhui, 246000, China

RECRUITING

Central Study Contacts

Xu si qi, Doctor

CONTACT

13865192106; errtg555@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 24, 2024
• Study Start: June 25, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

CN (1)