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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04706767
Enrollment
160
Registered
2021-01-13
Start date
2021-01-28
Completion date
2021-06-25
Last updated
2022-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Lidocaine, Dexmedetomidine, Quality of recovery

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.

Interventions

DRUGCo-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.

DRUGDexmedetomidine 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.

DRUGLidocaine 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.

DRUGSaline 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.

Sponsors

Anqing Municipal Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of recovery scores(QoR-40)1 day after operationOur primary outcome was Quality of recovery scores(QoR-40) 1 day after operation

Secondary

MeasureTime frameDescription
Recovery timeImmediately after the surgerySecondary Outcome Measure was recovery time
Extubation timeImmediately after the surgerySecondary Outcome Measure was extubation time
Pain visual analogue scale scoresThe first 24 hours after operationSecondary Outcome Measure was pain visual analogue scale scores
Intraoperative remifentanil total doseIntraoperativeSecondary Outcome Measure was remifentanil total dose during the perioperative period
The consumption of sufentanilThe first 24 hours after operationSecondary Outcome Measure was consumption of sufentanil
The length of post-anesthesiacare unit stayImmediately after the surgerySecondary Outcome Measure was the length of post-anesthesiacare unit stay
PONV scoresThe first 24 hours after operationSecondary Outcome Measure was PONV scores

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026