NCT04633577

Brief Summary

Lidocaine, an amide local anesthetic, has advantages of low price and easily obtaining. Intravenous lidocaine (IVL)initially has been used in the treatment of arrhythmia. It was demonstrated that IVL had analgesic effect, especially in colorectal surgery, but remained controversy in other types of surgeries. Other beneficial effects, such as prevention of hyperalgesia and propofol-induced injection pain, reduction of incidence of postoperative ileus and nausea and vomiting and anti-inflammatory also were proposed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 12, 2020

Last Update Submit

November 8, 2022

Conditions

Analgesia

Keywords

intravenous lidocainepropofolpain scorefatigue scoredose

Outcome Measures

Primary Outcomes (1)

  • Propofol Requirements

    propofol requirements at loss of conciousness and supplemental requirements during procedure

    from loss of conciousness to end of procedure

Secondary Outcomes (2)

  • Pain score

    immediately, 15 min, 30 min in PACU

  • Fatigue score

    immediately, 15 min, 30 min in PACU

Study Arms (2)

Group Lidocaine

EXPERIMENTAL

20 eligible patients are received 1.5mg/kg 1%lidocaine intravenously over 30-60s. Then, 4mg/kg/h lidocaine infused intravenously until end of procedure.

Drug: Lidocaine IV

Group Control

PLACEBO COMPARATOR

2020 eligible patients are received equal 0.9% normal saline.

Drug: 0.9% normal saline

Interventions

Lidocaine IVDRUG

A bolos of 1.5mg/kg lidocaine will be administered before induction. Then, infusion of 4mg/kg/h lidocaine will maintain during procedure.

Group Lidocaine
0.9% normal salineDRUG

0.9% normal saline

Group Control

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female could undergo hysteroscopy and diagnostic curettage
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent hysteroscopy and diagnostic curettage, American Society of Anesthesiologist' physical status 1-2, BMI 18.5-24.9 kg/m2,

You may not qualify if:

  • Patients with known allergy to lidocaine or other local anesthetics, taken sedatives and analgesics within 1 week before surgery, mental and neurological diseases, hearing impairment, unwilling to sign informed consent or participate in the study, serious arrhythmia and organic heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Related Publications (2)

  • Forster C, Vanhaudenhuyse A, Gast P, Louis E, Hick G, Brichant JF, Joris J. Intravenous infusion of lidocaine significantly reduces propofol dose for colonoscopy: a randomised placebo-controlled study. Br J Anaesth. 2018 Nov;121(5):1059-1064. doi: 10.1016/j.bja.2018.06.019. Epub 2018 Aug 1.

    PMID: 30336850BACKGROUND

  • Chen M, Lu Y, Liu H, Fu Q, Li J, Wu J, Shangguan W. The propofol-sparing effect of intravenous lidocaine in elderly patients undergoing colonoscopy: a randomized, double-blinded, controlled study. BMC Anesthesiol. 2020 May 30;20(1):132. doi: 10.1186/s12871-020-01049-z.

    PMID: 32473649BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 18, 2020

Study Start

November 20, 2020

Primary Completion

December 25, 2020

Study Completion

December 30, 2020

Last Updated

November 14, 2022

Record last verified: 2020-11

Locations

CN(1)