Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy

NCT ID: NCT06469866

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2024-11-25

Brief Summary

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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

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Conditions

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Neuromuscular Blockade Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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

low-pressure pneumoperitoneum (LPP) with deep NMB.

Group Type EXPERIMENTAL

low-pressure pneumoperitoneum

Intervention Type DEVICE

low-pressure pneumoperitoneum (LPP) with deep NMB.

standard-pressure pneumoperitoneum

Intervention Type DEVICE

standard-pressure pneumoperitoneum (SPP) with moderate NMB.

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

standard-pressure pneumoperitoneum (SPP) with moderate NMB.

Group Type EXPERIMENTAL

low-pressure pneumoperitoneum

Intervention Type DEVICE

low-pressure pneumoperitoneum (LPP) with deep NMB.

standard-pressure pneumoperitoneum

Intervention Type DEVICE

standard-pressure pneumoperitoneum (SPP) with moderate NMB.

Interventions

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low-pressure pneumoperitoneum

low-pressure pneumoperitoneum (LPP) with deep NMB.

Intervention Type DEVICE

standard-pressure pneumoperitoneum

standard-pressure pneumoperitoneum (SPP) with moderate NMB.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Anqing Municipal Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anqing Munucipal Hospital Anesthesiology

Anqing, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xu si qi, Doctor

Role: CONTACT

13865192106

Facility Contacts

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xu siqi

Role: primary

Role: backup

13865192106

Other Identifiers

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xuzhang520

Identifier Type: -

Identifier Source: org_study_id

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