LidocaineNCT03809923
Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
A study testing lidocaine and dexmedetomidine infusion, Saline infusion and Lidocaine infusion in people with Lidocaine and Dexmedetomidine, run by Anqing Municipal Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lidocaine, Dexmedetomidine, Nausea and Vomiting, Postoperative
- What is being tested?
- lidocaine and dexmedetomidine infusion, Saline infusion and Lidocaine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 12 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
- Aged 40-60 years
- Scheduled for elective laparoscopic hysterectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combination Intravenous Dexmedetomidine and Lidocaine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy With General Anesthesia
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.
- Being tested
- lidocaine and dexmedetomidine infusion, Saline infusion, Lidocaine infusion, Dexmedetomidine infusion
- Keywords
- Lidocaine, Dexmedetomidine, Postoperative nausea and vomiting, laparoscopic hysterectomy
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine and dexmedetomidine infusionDrug
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 infusionDrug
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
Lidocaine infusionDrug
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 infusionDrug
Also called Dexmedetomidine
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Combined With Lidocaine Infusion Affect PONV | Experimental | Not described Receives: Drug: lidocaine and dexmedetomidine infusion; Drug: Saline infusion; Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion |
| Effect of infusion saline on PONV | Experimental | Not described Receives: Drug: lidocaine and dexmedetomidine infusion; Drug: Saline infusion; Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion |
| Effect of infusion lidocaine on PONV | Experimental | Not described Receives: Drug: lidocaine and dexmedetomidine infusion; Drug: Saline infusion; Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion |
| Effect of infusion dexmedetomidine on PONV | Experimental | Not described Receives: Drug: lidocaine and dexmedetomidine infusion; Drug: Saline infusion; Drug: Lidocaine infusion; Drug: Dexmedetomidine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea
Our primary outcome was the incidence of nausea during the 0-2 hours after surgery
Measured: 0-2 hours after surgery
postoperative nausea
Our primary outcome was the incidence of nausea during the 2-24 hours after surgery
Measured: 2-24 hours after surgery
postoperative nausea
Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
Measured: 24-48 hours after surgery
postoperative vomiting
Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery
Measured: 0-2 hours after surgery
postoperative vomiting
Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery
Measured: 2-24 hours after surgery
postoperative vomiting
Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery
Measured: 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
Measured: 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
Measured: 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
Measured: 24-48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Jun 2019
- Primary completion1 Aug 2020
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LidocaineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anqing Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809923
- Sponsor's protocol ID
- xuwen
- Status last verified
- Mar 2022
- First submitted
- 16 Jan 2019
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34348668
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combination Intravenous Dexmedetomidine and Lidocaine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy With General Anesthesia
- ClinicalTrials.gov ID
- NCT03809923
- Acronym / sponsor ID
- xuwen
- Keywords
- Lidocaine, Dexmedetomidine, Postoperative nausea and vomiting, laparoscopic hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Anqing Municipal HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
- Aged 40-60 years
- Scheduled for elective laparoscopic hysterectomy
Key exclusion criteria (8 listed)
- History of allergy to local anesthetics
- BMI>30
- Severe respiratory disease
- Renal or hepatic insufficiency
- History of preoperative opioids medication and psychiatric
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine and dexmedetomidine infusionPatients 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 | 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 infusionPatients 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 | 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 infusionpatients 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 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 infusionAlso: DexmedetomidinePatients 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. | Drug | 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 |
Primary outcome
postoperative nausea
Time frame: 0-2 hours after surgery
Our primary outcome was the incidence of nausea during the 0-2 hours after surgery
postoperative nausea
Time frame: 2-24 hours after surgery
Our primary outcome was the incidence of nausea during the 2-24 hours after surgery
postoperative nausea
Time frame: 24-48 hours after surgery
Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
postoperative vomiting
Time frame: 0-2 hours after surgery
Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery
postoperative vomiting
Time frame: 2-24 hours after surgery
Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery
postoperative vomiting
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 24-48 hours after surgery
Our primary outcome was the incidence of PONV during the 24-48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 34348668Xu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine and dexmedetomidine infusion, Saline infusion and Lidocaine infusion in people with Lidocaine and Dexmedetomidine, run by Anqing Municipal Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative nausea (time frame: 0-2 hours after surgery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.