Effect of Intravenous Lidocaine on Propofol Requirements

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Drug: Lidocaine IV; Drug: 0.9% normal saline

• Registration Number: NCT04633577
• Lead Sponsor: General Hospital of Ningxia Medical University

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.

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 Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-18
• Study Start: 2020-11-20
• Primary Completion: 2020-12-25
• Study Completion: 2020-12-30
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Lidocaine	Lidocaine IV	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 Control	0.9% normal saline	2020 eligible patients are received equal 0.9% normal saline.

Primary Outcome Measures

Name	Time	Method
Propofol Requirements	from loss of conciousness to end of procedure	propofol requirements at loss of conciousness and supplemental requirements during procedure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China