Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery
Effects of Lidocaine, Dexmedetomidine, and Their Combination on Quality of Recovery Undergoing Laparoscopic Total Hysterectomy
1 other identifier
interventional
160
1 country
1
Brief Summary
BACKGROUND: Some studies have revealed that intravenous (IV) lidocaine or dexmedetomidine might improve the quality of recovery undergoing laparoscopic surgery. The investigators investigated whether co-administration lidocaine and dexmedetomidine could better improve the the quality of recovery after laparoscopic total hysterectomy. METHODS: One hundred and forty-four women with elective laparoscopic total hysterectomy were randomly divided into four groups: Patients in group L received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close the pneumoperitoneum. Patients in group D received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close the pneumoperitoneum. Patients in group LD received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close the pneumoperitoneum, respectively. Patients in group C received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close the pneumoperitoneum. Primary outcome was the quality of recovery (QoR-40) at 1 day prior to sugery, 1 day after sugery, and 2 days after sugery. The secondary outcomes included perioperative remifentanil consumption, postoperative VAS scores, the incidence of postoperative nausea and vomiting, postoperative rescue analgesics and anti-emetics, recovery time, extubation time, and Ramsay sedation scale at 5 min, 10min, 30 min, 60 min after extubation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedStudy Start
First participant enrolled
January 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2021
CompletedMarch 10, 2022
March 1, 2022
5 months
January 11, 2021
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of recovery scores(QoR-40)
Our primary outcome was Quality of recovery scores(QoR-40) 1 day after operation
1 day after operation
Secondary Outcomes (7)
Intraoperative remifentanil total dose
Intraoperative
Recovery time
Immediately after the surgery
Extubation time
Immediately after the surgery
Pain visual analogue scale scores
The first 24 hours after operation
PONV scores
The first 24 hours after operation
- +2 more secondary outcomes
Study Arms (4)
Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery
EXPERIMENTALEffect of Dexmedetomidine infusion on Quality of Recovery
EXPERIMENTALEffect of Lidocaine infusion on Quality of Recovery
EXPERIMENTALEffect of saline infusion on Quality of Recovery
EXPERIMENTALInterventions
Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close of the pneumoperitoneum, respectively.
Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close of the pneumoperitoneum.
Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close of the pneumoperitoneum.
Patients received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close of the pneumoperitoneum.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
- Scheduled for elective laparoscopic total hysterectomy
You may not qualify if:
- History of allergy to local anesthetics
- BMI\>30
- Severe respiratory disease
- Renal or hepatic insufficiency
- History of preoperative opioids medication and psychiatric
- preoperative bradycardia
- preoperative atrioventricular block
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anqing Hospital Anesthesiology
Anqing, Anhui, 246000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2021
First Posted
January 13, 2021
Study Start
January 28, 2021
Primary Completion
June 25, 2021
Study Completion
June 25, 2021
Last Updated
March 10, 2022
Record last verified: 2022-03