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NCT Number: NCT04706767

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, 246000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Co-administration Lidocaine and Dexmedetomidine

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

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

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

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.

Primary outcomes

  1. Quality of recovery scores(QoR-40)

    Time frame: 1 day after operation

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

Secondary outcomes

  1. Intraoperative remifentanil total dose

    Time frame: Intraoperative

    Secondary Outcome Measure was remifentanil total dose during the perioperative period

  2. Recovery time

    Time frame: Immediately after the surgery

    Secondary Outcome Measure was recovery time

  3. Extubation time

    Time frame: Immediately after the surgery

    Secondary Outcome Measure was extubation time

  4. Pain visual analogue scale scores

    Time frame: The first 24 hours after operation

    Secondary Outcome Measure was pain visual analogue scale scores

  5. PONV scores

    Time frame: The first 24 hours after operation

    Secondary Outcome Measure was PONV scores

  6. The consumption of sufentanil

    Time frame: The first 24 hours after operation

    Secondary Outcome Measure was consumption of sufentanil

  7. The length of post-anesthesiacare unit stay

    Time frame: Immediately after the surgery

    Secondary Outcome Measure was the length of post-anesthesiacare unit stay

Sponsors and collaborators

Lead sponsor

Anqing Municipal Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2021
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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