LidocaineNCT03788018
Effect of Lidocaine Plus Dexmedetomidine Infusion on PONV
A study testing lidocaine and dexmedetomidine IV and saline IV in people with Lidocaine and Dexmedetomidine, run by Xu Siqi 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 55 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 IV and saline IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2018
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
- Aged 40-55 years
- Scheduled for elective laparoscopic hysterectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Lidocaine Combined With Dexmedetomidine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy
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.
- Being tested
- lidocaine and dexmedetomidine IV, saline IV
- 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 IVDrug
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 IVDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Effect of IV lidocaine and dexmedetomidine on PONV | Experimental | Not described Receives: Drug: lidocaine and dexmedetomidine IV; Drug: saline IV |
| Effect of IV saline on PONV | Experimental | Not described Receives: Drug: lidocaine and dexmedetomidine IV; Drug: saline IV |
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 posted27 Dec 2018
- Study start1 Jan 2018
- Primary completion15 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xu Siqi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Siqi, Anqing Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788018
- Sponsor's protocol ID
- AnqingMH
- Status last verified
- Jan 2019
- First submitted
- 20 Dec 2018
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Lidocaine Combined With Dexmedetomidine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT03788018
- Acronym / sponsor ID
- AnqingMH
- Keywords
- Lidocaine, Dexmedetomidine, Postoperative nausea and vomiting, laparoscopic hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xu SiqiUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 27 Dec 2018 (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: 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of IV lidocaine and dexmedetomidine on PONV | Experimental | Drug: lidocaine and dexmedetomidine IV, Drug: saline IV |
| Effect of IV saline on PONV | Experimental | Drug: lidocaine and dexmedetomidine IV, Drug: saline IV |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
- Aged 40-55 years
- Scheduled for elective laparoscopic hysterectomy
Key exclusion criteria (7 listed)
- History of allergy to local anesthetics
- Severe respiratory disease
- Renal or hepatic insufficiency
- History of preoperative opioids medication and psychiatric
- preoperative bradycardia
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 IVPatients 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 | Effect of IV lidocaine and dexmedetomidine on PONV, Effect of IV saline on PONV |
| saline IVPatients 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 | Effect of IV lidocaine and dexmedetomidine on PONV, Effect of IV 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 8 Jan 2019.
- Individual participant dataSharing planned: No
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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 IV and saline IV in people with Lidocaine and Dexmedetomidine, run by Xu Siqi 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 7 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 8 Jan 2019. 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?
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 8 Jan 2019.