Actively Recruiting
Effect of Deep Neuromuscular Block on the Quality of Recovery After Laparoscopic Hysterectomy
Led by Anqing Municipal Hospital · Updated on 2024-06-24
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether deep neuromuscular block (NMB) can improve recovery quality after laparoscopic hysterectomy compared to moderate NMB. This study focuses on women undergoing elective laparoscopic hysterectomy and evaluates surgical conditions, postoperative pain, and recovery quality. The trial is randomized and triple-blinded, aiming to clarify if deeper muscle relaxation during surgery benefits patients. Participants are divided into two groups: one receives low-pressure pneumoperitoneum (LPP) at 8-10 mmHg with deep NMB, and the other receives standard-pressure pneumoperitoneum (SPP) at 12-14 mmHg with moderate NMB. These interventions are applied during laparoscopic hysterectomy to assess their effect on surgical conditions and recovery. During the study, researchers will measure the quality of recovery one day after surgery using the QoR-15 score. They will also monitor postoperative pain, shoulder pain within 24 hours, nausea, vomiting, analgesic use, time to first flatus, and tracheal tube removal time. The study includes follow-up assessments to evaluate these outcomes and ensure participant safety throughout the process.
CONDITIONS
Brief Title
Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants
- Aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I to III
- Scheduled for elective laparoscopic hysterectomy
You will not qualify if you...
- Unable to give informed consent
- Body mass index (BMI) greater than 35
- Renal or hepatic insufficiency
- History of preoperative psychiatric conditions
- Previous surgery at the procedure site
- Presence of neuromuscular disease
- Pregnancy
- Contraindications to study medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo laparoscopic hysterectomy using either low-pressure or standard-pressure pneumoperitoneum with neuromuscular block.
1 surgery visit and immediate post-operative monitoring
Duration - 24 hours after operation
Participants are monitored for quality of recovery, shoulder pain, and postoperative nausea and vomiting during the first 24 hours after surgery.
1 follow-up visit within 1 day after surgery
Trial Site Locations
Total: 1 location
1
Department of Anqing Munucipal Hospital Anesthesiology
Anqing, Anhui, China, 246000
Actively Recruiting
Research Team
X
Xu si qi, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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