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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03788018
Other study ID # AnqingMH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date December 1, 2018

Study information

Verified date January 2019
Source Anqing Municipal Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

BACKGROUND: Few researches have manifested that intravenous (IV) lidocaine or dexmedetomidine decreased the incidence of postoperative nausea and vomiting (PONV). The investigators investigated whether IV lidocaine plus dexmedetomidine infusion could better reduce the incidence of PONV after laparoscopic hysterectomy.

METHODS: One hundred and twenty women with elective laparoscopic hysterectomy were randomly divided into two groups: patients in the lidocaine combined with dexmedetomidine group (LD group, n=60) received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine (0.5 μg/kg loading, 0.4 μg/kg/h infusion) respectively. Patients in the control group (CON group, n=60) received the equal volume of saline. Primary outcome was the incidence of the first 48 h nausea, vomiting and PONV after surgery. The secondary outcomes included perioperative propofol and remifentanil consumption, postoperative fentanyl requirement, Ramsay sedation score, and bradycardia during post-anaesthesia care unit (PACU) stay.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 1, 2018
Est. primary completion date November 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 55 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists (ASA) physical status?and ?

- Aged 40-55 years

- Scheduled for elective laparoscopic hysterectomy

Exclusion Criteria:

- History of allergy to local anesthetics

- Severe respiratory disease

- Renal or hepatic insufficiency

- History of preoperative opioids medication and psychiatric

- preoperative bradycardia

- preoperative atrioventricular block

- Subjects who experienced severe hypotension (mean arterial pressure [MAP] <60 mmHg) or bradycardia (heart rate [HR] <40 bpm), urticaria, or arrhythmia during lidocaine and dexmedetomidine infusion period

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
lidocaine and dexmedetomidine IV
Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively.
saline IV
Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery

Locations

Country Name City State
China Department of Anqing Hospital Anesthesiology Anqing Anhui

Sponsors (1)

Lead Sponsor Collaborator
Xu Siqi

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative nausea Our primary outcome was the incidence of nausea during the 0-2 hours after surgery 0-2 hours after surgery
Primary postoperative nausea Our primary outcome was the incidence of nausea during the 2-24 hours after surgery 2-24 hours after surgery
Primary postoperative nausea Our primary outcome was the incidence of nausea during the 24-48 hours after surgery 24-48 hours after surgery
Primary postoperative vomiting Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery 0-2 hours after surgery
Primary postoperative vomiting Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery 2-24 hours after surgery
Primary postoperative vomiting Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery 24-48 hours after surgery
Primary postoperative nausea and vomiting (PONV) Our primary outcome was the incidence of PONV during the 0-2 hours after surgery 0-2 hours after surgery
Primary postoperative nausea and vomiting (PONV) Our primary outcome was the incidence of PONV during the 2-24 hours after surgery 2-24 hours after surgery
Primary postoperative nausea and vomiting (PONV) Our primary outcome was the incidence of PONV during the 24-48 hours after surgery 24-48 hours after surgery
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