Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-26 @ 1:43 PM
Study NCT ID:
NCT04706767
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery
Sponsor:
Anqing Municipal Hospital
Organization:
Study Overview
Official Title:
Effects of Lidocaine, Dexmedetomidine, and Their Combination on Quality of Recovery Undergoing Laparoscopic Total Hysterectomy
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: