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Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06469866
Enrollment
72
Registered
2024-06-24
Start date
2024-06-25
Completion date
2024-11-25
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopy, Neuromuscular Blockade

Keywords

Neuromuscular block, Recovery, Laparoscopic hysterectomy

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.

Interventions

low-pressure pneumoperitoneum (LPP) with deep NMB.

standard-pressure pneumoperitoneum (SPP) with moderate NMB.

Sponsors

Anqing Municipal Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of recovery1 day after operationPrimary 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

MeasureTime frameDescription
Shoulder painThe first 24 hours after operationSecondary Outcome Measure was the incidence of shoulder pain
Postoperative nausea and vomitingThe first 24 hours after operationSecondary 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).

Countries

China

Contacts

Primary ContactXu si qi, Doctor
errtg555@163.com13865192106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026