Clinical trial NCT04706767: Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery
Official title: Effects of Lidocaine, Dexmedetomidine, and Their Combination on Quality of Recovery Undergoing Laparoscopic Total Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lidocaine
Dexmedetomidine
Quality of Recovery(QoR-40), Preoperative and Postoperative
Keywords: Lidocaine
Dexmedetomidine
Quality of recovery
Lead sponsor: Anqing Municipal Hospital
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 160
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Quality of recovery scores(QoR-40)
timeFrame: 1 day after operation
Secondary outcomes:
measure: Intraoperative remifentanil total dose
timeFrame: Intraoperative
measure: Recovery time
timeFrame: Immediately after the surgery
measure: Extubation time
timeFrame: Immediately after the surgery
measure: Pain visual analogue scale scores
timeFrame: The first 24 hours after operation
measure: PONV scores
timeFrame: The first 24 hours after operation
measure: The consumption of sufentanil
timeFrame: The first 24 hours after operation
measure: The length of post-anesthesiacare unit stay
timeFrame: Immediately after the surgery
Other outcomes:
Locations:
city: Anqing
country: China
facility: Department of Anqing Hospital Anesthesiology
state: Anhui
Study officials:
References: