Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAnqing Municipal Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅲ
Scheduled for elective laparoscopic hysterectomy
Disqualifiers
Inability to give informed consent
BMI >35
Renal or hepatic insufficiency
History of preoperative psychiatric
Trial design
Design model
Parallel
Treatments tested in this trial
low-pressure pneumoperitoneum
Devicelow-pressure pneumoperitoneum (LPP) with deep NMB.
standard-pressure pneumoperitoneum
Devicestandard-pressure pneumoperitoneum (SPP) with moderate NMB.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recoveryExperimental treatment 2 interventions
Group B: standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recoveryExperimental treatment 2 interventions
Trial outcomes
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
Time frame
1 day after operationSecondary outcomes
1
Shoulder pain
Secondary Outcome Measure was the incidence of shoulder pain
Time frame
The first 24 hours after operation2
Postoperative nausea and vomiting
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).
Time frame
The first 24 hours after operationSponsors and contacts
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Source ClinicalTrials.gov