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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04706767
Other study ID # xuzhang
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 28, 2021
Est. completion date June 25, 2021

Study information

Verified date March 2022
Source Anqing Municipal Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date June 25, 2021
Est. primary completion date June 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - American Society of Anesthesiologists (ASA) physical status?and ? - Scheduled for elective laparoscopic total hysterectomy Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Co-administration Lidocaine and Dexmedetomidine
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.
Dexmedetomidine infusion
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.
Lidocaine infusion
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.
Saline infusion
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.

Locations

Country Name City State
China Department of Anqing Hospital Anesthesiology Anqing Anhui

Sponsors (1)

Lead Sponsor Collaborator
Anqing Municipal Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Intraoperative remifentanil total dose Secondary Outcome Measure was remifentanil total dose during the perioperative period Intraoperative
Secondary Recovery time Secondary Outcome Measure was recovery time Immediately after the surgery
Secondary Extubation time Secondary Outcome Measure was extubation time Immediately after the surgery
Secondary Pain visual analogue scale scores Secondary Outcome Measure was pain visual analogue scale scores The first 24 hours after operation
Secondary PONV scores Secondary Outcome Measure was PONV scores The first 24 hours after operation
Secondary The consumption of sufentanil Secondary Outcome Measure was consumption of sufentanil The first 24 hours after operation
Secondary The length of post-anesthesiacare unit stay Secondary Outcome Measure was the length of post-anesthesiacare unit stay Immediately after the surgery
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