Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery

NCT ID: NCT04706767

Last Updated: 2022-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-28

Study Completion Date

2021-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Lidocaine Dexmedetomidine Quality of Recovery(QoR-40), Preoperative and Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery

Group Type EXPERIMENTAL

Co-administration Lidocaine and Dexmedetomidine

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Effect of Dexmedetomidine infusion on Quality of Recovery

Group Type EXPERIMENTAL

Co-administration Lidocaine and Dexmedetomidine

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Effect of Lidocaine infusion on Quality of Recovery

Group Type EXPERIMENTAL

Co-administration Lidocaine and Dexmedetomidine

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Effect of saline infusion on Quality of Recovery

Group Type EXPERIMENTAL

Co-administration Lidocaine and Dexmedetomidine

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
* 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Anqing Municipal Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anqing Hospital Anesthesiology

Anqing, Anhui, China

Site Status

Countries

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China

Other Identifiers

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xuzhang

Identifier Type: -

Identifier Source: org_study_id

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