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

Sponsors

Lead Sponsor: Anqing Municipal Hospital

Source Anqing Municipal Hospital
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.

Overall Status Recruiting
Start Date February 1, 2021
Completion Date August 31, 2021
Primary Completion Date August 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Quality of recovery scores(QoR-40) 1 day prior to operation
Quality of recovery scores(QoR-40) 1 day after operation
Quality of recovery scores(QoR-40) 2 days after operation
Enrollment 36
Condition
Intervention

Intervention Type: Drug

Intervention Name: Co-administration Lidocaine and Dexmedetomidine

Description: 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

Intervention Name: Dexmedetomidine infusion

Description: 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

Intervention Name: Lidocaine infusion

Description: 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

Intervention Name: Saline infusion

Description: 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:

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

Gender: Female

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Xu Si Qi, Doctor

Phone: 13865192106

Email: [email protected]

Location
Facility: Status: Contact: Department of Anqing Hospital Anesthesiology Xu Si Qi
Location Countries

China

Verification Date

January 2021

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 4
Arm Group

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

Type: Experimental

Label: Effect of Dexmedetomidine infusion on Quality of Recovery

Type: Experimental

Label: Effect of Lidocaine infusion on Quality of Recovery

Type: Experimental

Label: Effect of saline infusion on Quality of Recovery

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov