Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
Primary Purpose
Lidocaine, Dexmedetomidine, Nausea and Vomiting, Postoperative
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
lidocaine and dexmedetomidine infusion
Saline infusion
Lidocaine infusion
Dexmedetomidine infusion
Sponsored by
About this trial
This is an interventional other trial for Lidocaine focused on measuring Lidocaine, Dexmedetomidine, Postoperative nausea and vomiting, laparoscopic hysterectomy
Eligibility Criteria
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
Sites / Locations
- Department of Anqing Hospital Anesthesiology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
Effect of infusion saline on PONV
Effect of infusion lidocaine on PONV
Effect of infusion dexmedetomidine on PONV
Arm Description
Outcomes
Primary Outcome Measures
postoperative nausea
Our primary outcome was the incidence of nausea during the 0-2 hours after surgery
postoperative nausea
Our primary outcome was the incidence of nausea during the 2-24 hours after surgery
postoperative nausea
Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
postoperative vomiting
Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery
postoperative vomiting
Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery
postoperative vomiting
Our primary outcome was the incidence of vomiting during the 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
postoperative nausea and vomiting (PONV)
Our primary outcome was the incidence of PONV during the 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
Secondary Outcome Measures
Full Information
NCT ID
NCT03809923
First Posted
January 16, 2019
Last Updated
March 10, 2022
Sponsor
Anqing Municipal Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03809923
Brief Title
Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
Official Title
Effects of Combination Intravenous Dexmedetomidine and Lidocaine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy With General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
January 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anqing Municipal Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lidocaine, Dexmedetomidine, Nausea and Vomiting, Postoperative
Keywords
Lidocaine, Dexmedetomidine, Postoperative nausea and vomiting, laparoscopic hysterectomy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
Arm Type
Experimental
Arm Title
Effect of infusion saline on PONV
Arm Type
Experimental
Arm Title
Effect of infusion lidocaine on PONV
Arm Type
Experimental
Arm Title
Effect of infusion dexmedetomidine on PONV
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lidocaine and dexmedetomidine infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline infusion
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lidocaine infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine infusion
Other Intervention Name(s)
Dexmedetomidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative nausea
Description
Our primary outcome was the incidence of nausea during the 0-2 hours after surgery
Time Frame
0-2 hours after surgery
Title
postoperative nausea
Description
Our primary outcome was the incidence of nausea during the 2-24 hours after surgery
Time Frame
2-24 hours after surgery
Title
postoperative nausea
Description
Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
Time Frame
24-48 hours after surgery
Title
postoperative vomiting
Description
Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery
Time Frame
0-2 hours after surgery
Title
postoperative vomiting
Description
Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery
Time Frame
2-24 hours after surgery
Title
postoperative vomiting
Description
Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery
Time Frame
24-48 hours after surgery
Title
postoperative nausea and vomiting (PONV)
Description
Our primary outcome was the incidence of PONV during the 0-2 hours after surgery
Time Frame
0-2 hours after surgery
Title
postoperative nausea and vomiting (PONV)
Description
Our primary outcome was the incidence of PONV during the 2-24 hours after surgery
Time Frame
2-24 hours after surgery
Title
postoperative nausea and vomiting (PONV)
Description
Our primary outcome was the incidence of PONV during the 24-48 hours after surgery
Time Frame
24-48 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anqing Hospital Anesthesiology
City
Anqing
State/Province
Anhui
ZIP/Postal Code
246000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34348668
Citation
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.
Results Reference
derived
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Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
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