Effect of Intravenous Lidocaine on Propofol Requirements

Sponsor

General Hospital of Ningxia Medical University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04633577

Collaborator

(none)

Enrollment

Location

Arms

6.9

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Drug: Lidocaine Iv Drug: 0.9% normal saline	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

The Effect of Intravenous Lidocaine on Propofol Requirements in Patients Undergoing Hysteroscopy and Diagnostic Curettage

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Mar 30, 2021

Anticipated Study Completion Date :

Mar 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: Group Control 2020 eligible patients are received equal 0.9% normal saline.	Drug: 0.9% normal saline 0.9% normal saline

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Placebo Comparator: Group Control

2020 eligible patients are received equal 0.9% normal saline.

Drug: 0.9% normal saline

0.9% normal saline

Outcome Measures

Primary Outcome Measures

Propofol Requirements [from loss of conciousness to end of procedure]
propofol requirements at loss of conciousness and supplemental requirements during procedure

Secondary Outcome Measures

Pain score [immediately, 15 min, 30 min in PACU]
Assessed pain score using 0-10 cm VAS
Fatigue score [immediately, 15 min, 30 min in PACU]
Assessed fatigue score using 0-10 cm VAS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.