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

Dexmedetomidine Clinical Trial

Official title:

Effects of Lidocaine, Dexmedetomidine, and Their Combination on Quality of Recovery Undergoing Laparoscopic Total Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706767
• Other study ID #: xuzhang
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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