Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy

June 19, 2024 updated by: Anqing Municipal Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Anqing, Anhui, China, 246000
        • Recruiting
        • Department of Anqing Munucipal Hospital Anesthesiology
        • Contact:
        • Contact:
          • Phone Number: 13865192106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery
low-pressure pneumoperitoneum (LPP) with deep NMB.
Device: low-pressure pneumoperitoneum
low-pressure pneumoperitoneum (LPP) with deep NMB.
Device: standard-pressure pneumoperitoneum
standard-pressure pneumoperitoneum (SPP) with moderate NMB.
Experimental: standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery
standard-pressure pneumoperitoneum (SPP) with moderate NMB.
Device: low-pressure pneumoperitoneum
low-pressure pneumoperitoneum (LPP) with deep NMB.
Device: standard-pressure pneumoperitoneum
standard-pressure pneumoperitoneum (SPP) with moderate NMB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder pain
Time Frame: The first 24 hours after operation
Secondary Outcome Measure was the incidence of shoulder pain
The first 24 hours after operation
Postoperative nausea and vomiting
Time Frame: 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).
The first 24 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anqing Municipal Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 25, 2024

Primary Completion (Estimated)

November 25, 2024

Study Completion (Estimated)

November 25, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • xuzhang520

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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