LidocaineNCT04706767
Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery
A study testing Co-administration Lidocaine and Dexmedetomidine, Dexmedetomidine infusion and Lidocaine infusion in people with Lidocaine and Dexmedetomidine, run by Anqing Municipal Hospital at 1 site in China.
Trial summary
BACKGROUND: Some studies have revealed that intravenous (IV) lidocaine or dexmedetomidine might improve the quality of recovery undergoing laparoscopic surgery. The investigators investigated whether co-administration lidocaine and dexmedetomidine could better improve the the quality of recovery after laparoscopic… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lidocaine, Dexmedetomidine, Quality of Recovery(QoR-40), Preoperative and Postoperative
- What is being tested?
- Co-administration Lidocaine and Dexmedetomidine, Dexmedetomidine infusion and Lidocaine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2021to 25 Jun 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
- Scheduled for elective laparoscopic total 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Lidocaine, Dexmedetomidine, and Their Combination on Quality of Recovery Undergoing Laparoscopic Total Hysterectomy
BACKGROUND: Some studies have revealed that intravenous (IV) lidocaine or dexmedetomidine might improve the quality of recovery undergoing laparoscopic surgery. The investigators investigated whether co-administration lidocaine and dexmedetomidine could better improve the the quality of recovery after laparoscopic total hysterectomy.
METHODS: One hundred and forty-four women with elective laparoscopic total hysterectomy were randomly divided into four groups: Patients in group L received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close the pneumoperitoneum. Patients in group D received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close the pneumoperitoneum. Patients in group LD received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close the pneumoperitoneum, respectively. Patients in group C received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close the pneumoperitoneum. Primary outcome was the quality of recovery (QoR-40) at 1 day prior to sugery, 1 day after sugery, and 2 days after sugery. The secondary outcomes included perioperative remifentanil consumption, postoperative VAS scores, the incidence of postoperative nausea and vomiting, postoperative rescue analgesics and anti-emetics, recovery time, extubation time, and Ramsay sedation scale at 5 min, 10min, 30 min, 60 min after extubation.
- Being tested
- Co-administration Lidocaine and Dexmedetomidine, Dexmedetomidine infusion, Lidocaine infusion, Saline infusion
- Keywords
- Lidocaine, Dexmedetomidine, Quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-administration Lidocaine and DexmedetomidineDrug
Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close of the pneumoperitoneum, respectively.
Dexmedetomidine infusionDrug
Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close of the pneumoperitoneum.
Lidocaine infusionDrug
Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close of the pneumoperitoneum.
Saline infusionDrug
Patients received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close of the pneumoperitoneum.
| Study group | Role | What they receive |
|---|---|---|
| Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery | Experimental | Not described Receives: Drug: Co-administration Lidocaine and Dexmedetomidine; Drug: Dexmedetomidine infusion; Drug: Lidocaine infusion; Drug: Saline infusion |
| Effect of Dexmedetomidine infusion on Quality of Recovery | Experimental | Not described Receives: Drug: Co-administration Lidocaine and Dexmedetomidine; Drug: Dexmedetomidine infusion; Drug: Lidocaine infusion; Drug: Saline infusion |
| Effect of Lidocaine infusion on Quality of Recovery | Experimental | Not described Receives: Drug: Co-administration Lidocaine and Dexmedetomidine; Drug: Dexmedetomidine infusion; Drug: Lidocaine infusion; Drug: Saline infusion |
| Effect of saline infusion on Quality of Recovery | Experimental | Not described Receives: Drug: Co-administration Lidocaine and Dexmedetomidine; Drug: Dexmedetomidine infusion; Drug: Lidocaine infusion; Drug: Saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery scores(QoR-40)
Our primary outcome was Quality of recovery scores(QoR-40) 1 day after operation
Measured: 1 day after operation
Secondary outcomes (7)
Intraoperative remifentanil total dose
Secondary Outcome Measure was remifentanil total dose during the perioperative period
Measured: Intraoperative
Recovery time
Secondary Outcome Measure was recovery time
Measured: Immediately after the surgery
Extubation time
Secondary Outcome Measure was extubation time
Measured: Immediately after the surgery
Pain visual analogue scale scores
Secondary Outcome Measure was pain visual analogue scale scores
Measured: The first 24 hours after operation
PONV scores
Secondary Outcome Measure was PONV scores
Measured: The first 24 hours after operation
The consumption of sufentanil
Secondary Outcome Measure was consumption of sufentanil
Measured: The first 24 hours after operation
The length of post-anesthesiacare unit stay
Secondary Outcome Measure was the length of post-anesthesiacare unit stay
Measured: Immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start28 Jan 2021
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 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
- NCT04706767
- Sponsor's protocol ID
- xuzhang
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lidocaine, Dexmedetomidine, and Their Combination on Quality of Recovery Undergoing Laparoscopic Total Hysterectomy
- ClinicalTrials.gov ID
- NCT04706767
- Acronym / sponsor ID
- xuzhang
- Keywords
- Lidocaine, Dexmedetomidine, Quality of recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Anqing Municipal HospitalUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 13 Jan 2021 (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: Some studies have revealed that intravenous (IV) lidocaine or dexmedetomidine might improve the quality of recovery undergoing laparoscopic surgery. The investigators investigated whether co-administration lidocaine and dexmedetomidine could better improve the the quality of recovery after laparoscopic total hysterectomy.
METHODS: One hundred and forty-four women with elective laparoscopic total hysterectomy were randomly divided into four groups: Patients in group L received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close the pneumoperitoneum. Patients in group D received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close the pneumoperitoneum. Patients in group LD received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close the pneumoperitoneum, respectively. Patients in group C received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close the pneumoperitoneum. Primary outcome was the quality of recovery (QoR-40) at 1 day prior to sugery, 1 day after sugery, and 2 days after sugery. The secondary outcomes included perioperative remifentanil consumption, postoperative VAS scores, the incidence of postoperative nausea and vomiting, postoperative rescue analgesics and anti-emetics, recovery time, extubation time, and Ramsay sedation scale at 5 min, 10min, 30 min, 60 min after extubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery | Experimental | Drug: Co-administration Lidocaine and Dexmedetomidine, Drug: Dexmedetomidine infusion, Drug: Lidocaine infusion, Drug: Saline infusion |
| Effect of Dexmedetomidine infusion on Quality of Recovery | Experimental | Drug: Co-administration Lidocaine and Dexmedetomidine, Drug: Dexmedetomidine infusion, Drug: Lidocaine infusion, Drug: Saline infusion |
| Effect of Lidocaine infusion on Quality of Recovery | Experimental | Drug: Co-administration Lidocaine and Dexmedetomidine, Drug: Dexmedetomidine infusion, Drug: Lidocaine infusion, Drug: Saline infusion |
| Effect of saline infusion on Quality of Recovery | Experimental | Drug: Co-administration Lidocaine and Dexmedetomidine, Drug: Dexmedetomidine infusion, Drug: Lidocaine infusion, Drug: Saline infusion |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
- Scheduled for elective laparoscopic total hysterectomy
Key exclusion criteria (7 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 |
|---|---|---|
| Co-administration Lidocaine and DexmedetomidinePatients received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close of the pneumoperitoneum, respectively. | Drug | Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery, Effect of Dexmedetomidine infusion on Quality of Recovery, Effect of Lidocaine infusion on Quality of Recovery, Effect of saline infusion on Quality of Recovery |
| Dexmedetomidine infusionPatients received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close of the pneumoperitoneum. | Drug | Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery, Effect of Dexmedetomidine infusion on Quality of Recovery, Effect of Lidocaine infusion on Quality of Recovery, Effect of saline infusion on Quality of Recovery |
| Lidocaine infusionPatients received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close of the pneumoperitoneum. | Drug | Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery, Effect of Dexmedetomidine infusion on Quality of Recovery, Effect of Lidocaine infusion on Quality of Recovery, Effect of saline infusion on Quality of Recovery |
| Saline infusionPatients received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close of the pneumoperitoneum. | Drug | Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery, Effect of Dexmedetomidine infusion on Quality of Recovery, Effect of Lidocaine infusion on Quality of Recovery, Effect of saline infusion on Quality of Recovery |
Primary outcome
Quality of recovery scores(QoR-40)
Time frame: 1 day after operation
Our primary outcome was Quality of recovery scores(QoR-40) 1 day after operation
7 secondary outcomes
Intraoperative remifentanil total dose
Time frame: Intraoperative
Recovery time
Time frame: Immediately after the surgery
Extubation time
Time frame: Immediately after the surgery
Pain visual analogue scale scores
Time frame: The first 24 hours after operation
PONV scores
Time frame: The first 24 hours after operation
The consumption of sufentanil
Time frame: The first 24 hours after operation
The length of post-anesthesiacare unit stay
Time frame: Immediately after the 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 10 Mar 2022.
Related trials for Lidocaine
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
RecruitingPhase 4
Prospective RCT Lidocaine & Levobupivacaine on Block Dynamics After Subparaneural Popliteal Sciatic Nerve Block
Musculoskeletal Diseases or Conditions
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Not yet recruitingPhase 4
Effect of Midazolam Given at Induction on Recall of Propofol Injection Pain
Propofol Injection Pain, Postoperative Recall of Pain
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 Co-administration Lidocaine and Dexmedetomidine, Dexmedetomidine 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 2 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 10 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?
Quality of recovery scores(QoR-40) (time frame: 1 day after operation). 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 10 Mar 2022.