Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

NCT03809923 | Completed DMC

• 1 other identifier: xuwen
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Lidocaine; Dexmedetomidine; Nausea and Vomiting, Postoperative

Keywords

Lidocaine; Dexmedetomidine; Postoperative nausea and vomiting; laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (9)

• postoperative nausea

  Our primary outcome was the incidence of nausea during the 0-2 hours after surgery

  0-2 hours after surgery

• postoperative nausea

  Our primary outcome was the incidence of nausea during the 2-24 hours after surgery

  2-24 hours after surgery

• postoperative nausea

  Our primary outcome was the incidence of nausea during the 24-48 hours after surgery

  24-48 hours after surgery

• postoperative vomiting

  Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery

  0-2 hours after surgery

• postoperative vomiting

  Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery

  2-24 hours after surgery

• postoperative vomiting

  Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery

  24-48 hours after surgery

• 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

• 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

• 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

Study Arms (4)

Dexmedetomidine Combined With Lidocaine Infusion Affect PONV

EXPERIMENTAL

Drug: lidocaine and dexmedetomidine infusion; Drug: Saline infusion; Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion

Effect of infusion saline on PONV

EXPERIMENTAL

Drug: lidocaine and dexmedetomidine infusion; Drug: Saline infusion; Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion

Effect of infusion lidocaine on PONV

EXPERIMENTAL

Drug: lidocaine and dexmedetomidine infusion; Drug: Saline infusion; Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion

Effect of infusion dexmedetomidine on PONV

EXPERIMENTAL

Drug: lidocaine and dexmedetomidine infusion; Drug: Saline infusion; Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion

Interventions

lidocaine and dexmedetomidine infusion DRUG

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.

Dexmedetomidine Combined With Lidocaine Infusion Affect PONV; Effect of infusion dexmedetomidine on PONV; Effect of infusion lidocaine on PONV; Effect of infusion saline on PONV

Saline infusion DRUG

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

Dexmedetomidine Combined With Lidocaine Infusion Affect PONV; Effect of infusion dexmedetomidine on PONV; Effect of infusion lidocaine on PONV; Effect of infusion saline on PONV

Lidocaine infusion DRUG

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.

Dexmedetomidine Combined With Lidocaine Infusion Affect PONV; Effect of infusion dexmedetomidine on PONV; Effect of infusion lidocaine on PONV; Effect of infusion saline on PONV

Dexmedetomidine infusion DRUG

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.

Also known as: Dexmedetomidine

Dexmedetomidine Combined With Lidocaine Infusion Affect PONV; Effect of infusion dexmedetomidine on PONV; Effect of infusion lidocaine on PONV; Effect of infusion saline on PONV

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anqing Municipal Hospital: lead

Study Sites (1)

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, 246000, China

Location

Related Publications (1)

• Xu S, Wang S, Hu S, Ju X, Li Q, Li Y. Effects of lidocaine, dexmedetomidine, and their combination infusion on postoperative nausea and vomiting following laparoscopic hysterectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Aug 4;21(1):199. doi: 10.1186/s12871-021-01420-8.

  PMID: 34348668 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Lidocaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: June 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: January 12, 2021
• Last Updated: March 25, 2022

Record last verified: 2022-03

Locations

CN (1)