Effect of Intravenous Lidocaine on Propofol Requirements

NCT ID: NCT04633577

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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The most frequent drugs for procedural sedation and analgesia are propofol, benzodiazepines and opioids. However, these drugs may cause respiratory depression and circulatory instability. Combination will increase the risk of hypoxia and apnea.

In China, most anesthesia for hysteroscopy and gastroenteroscopy is procedural sedation and analgesia(PAS) provided by anesthetists. Foester et,al. have been tested that IVL could significantly reduce propofol requirements 、postoperative pain and fatigue scores in colonoscopy. Chen,et,al. find the same effect of IVL in elderly. However, there is no research reporting IVL used in hysteroscopy and diagnostic curettage. So, our main objective is to evaluate the effect of intravenous lidocaine on propofol requirements in patients undergoing hysteroscopy and diagnostic curettage.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group Lidocaine

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.

Group Type EXPERIMENTAL

Lidocaine IV

Intervention Type DRUG

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

Group Control

2020 eligible patients are received equal 0.9% normal saline.

Group Type PLACEBO_COMPARATOR

0.9% normal saline

Intervention Type DRUG

0.9% normal saline

Interventions

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Lidocaine IV

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

Intervention Type DRUG

0.9% normal saline

0.9% normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 30336850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32473649 (View on PubMed)

Other Identifiers

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2020-1000

Identifier Type: -

Identifier Source: org_study_id

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