Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

Sponsor

Anqing Municipal Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03809923

Collaborator

(none)

240

Enrollment

Location

Arms

19.4

Actual Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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: Two hundred and forty women with elective laparoscopic hysterectomy were randomly divided into four groups: the control group (group C, n=60) received an equal volume of saline, the lidocaine group (group L, n=60) received IV lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h continuous infusion), the dexmedetomidine group (group D, n=60) received dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4 µg/kg/h continuous infusion), the lidocaine plus dexmedetomidine group (group LD, n=60) received combination of lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h continuous infusion) and dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4 µg/kg/h continuous infusion). 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.

Condition or Disease	Intervention/Treatment	Phase
Lidocaine Dexmedetomidine Nausea and Vomiting, Postoperative	Drug: lidocaine and dexmedetomidine infusion Drug: Saline infusion Drug: Lidocaine infusion Drug: Dexmedetomidine infusion	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Effects of Combination Intravenous Dexmedetomidine and Lidocaine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy With General Anesthesia

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Jan 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine Combined With Lidocaine Infusion Affect PONV	Drug: lidocaine and dexmedetomidine infusion 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. Drug: Saline infusion 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 Drug: Lidocaine infusion patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively. Drug: Dexmedetomidine infusion Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively. Other Names: Dexmedetomidine
Experimental: Effect of infusion saline on PONV	Drug: lidocaine and dexmedetomidine infusion 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. Drug: Saline infusion 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 Drug: Lidocaine infusion patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively. Drug: Dexmedetomidine infusion Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively. Other Names: Dexmedetomidine
Experimental: Effect of infusion lidocaine on PONV	Drug: lidocaine and dexmedetomidine infusion 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. Drug: Saline infusion 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 Drug: Lidocaine infusion patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively. Drug: Dexmedetomidine infusion Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively. Other Names: Dexmedetomidine
Experimental: Effect of infusion dexmedetomidine on PONV	Drug: lidocaine and dexmedetomidine infusion 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. Drug: Saline infusion 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 Drug: Lidocaine infusion patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively. Drug: Dexmedetomidine infusion Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively. Other Names: Dexmedetomidine

Outcome Measures

Primary Outcome Measures

postoperative nausea [0-2 hours after surgery]
Our primary outcome was the incidence of nausea during the 0-2 hours after surgery
postoperative nausea [2-24 hours after surgery]
Our primary outcome was the incidence of nausea during the 2-24 hours after surgery
postoperative nausea [24-48 hours after surgery]
Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
postoperative vomiting [0-2 hours after surgery]
Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery
postoperative vomiting [2-24 hours after surgery]
Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery
postoperative vomiting [24-48 hours after surgery]
Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery
postoperative nausea and vomiting (PONV) [0-2 hours after surgery]
Our primary outcome was the incidence of PONV during the 0-2 hours after surgery
postoperative nausea and vomiting (PONV) [2-24 hours after surgery]
Our primary outcome was the incidence of PONV during the 2-24 hours after surgery
postoperative nausea and vomiting (PONV) [24-48 hours after surgery]
Our primary outcome was the incidence of PONV during the 24-48 hours after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
Aged 40-60 years
Scheduled for elective laparoscopic 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
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