Dose Systemic Lidocaine Improve the Quality of Recovery After Colorectal Endoscopic Submucosal Dissection

Fujian Provincial Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Recovery

Treatments: Drug: Propofol; Drug: Sufentanil; Drug: 0.9% saline; Drug: lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05750056

K2020-05-029-02

Details and patient eligibility

About

Endoscopic submucosal dissection (ESD) is a common procedure that requires a long procedural time. Procedure Sedation is commonly provided to alleviate patients' discomfort and facilitate the implementation of procedures. We conducted a prospective study to determine the effect of intravenous infusion of lidocaine in the cognitive domain of the postoperative quality of recovery scale on day 3 after ESD.

Full description

Colorectal cancer occurred in more than 1.9 million new cases and 935,000 deaths in 2020 and ranked third in incidence and second in mortality globally. Endoscopic submucosal dissection (ESD) is the current standard for treating large colorectal polyps and has been shown to reduce colorectal cancer-related mortality. Sedation is commonly provided to alleviate patients' discomfort and facilitate the implementation of procedures.

Lidocaine is an amide local anesthetic with analgesic, anti-hyperalgesic, and anti-inflammatory properties. Its safety in appropriate amounts has been established. The current evidence gap is whether the use of systematic lidocaine affects the quality of recovery after ESD. Thus, the aim of this study is to determine the effect of intravenous infusion of lidocaine in the cognitive domain of the postoperative quality of recovery scale on day 3 after ESD.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. American Society of Anesthesiologists (ASA) classification I-III;
2. Scheduled for endoscopic colorectal mucosal dissection.

Exclusion criteria

1. Patient refuses to participate;
2. BMI greater than 30;
3. Allergic or contraindication to study drugs;
4. History of chronic pain and long-term use of analgesic medication;
5. Severe arrhythmia;
6. Hepatic and renal dysfunction;
7. Any other conditions precluded study inclusion, such as cognitive impairment, pregnancy, or inability to communicate in Mandarin Chinese.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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234 participants in 2 patient groups, including a placebo group

Lidocaine group

Experimental group

Description:

Patients received an intravenous bolus injection of lidocaine 1.5 mg/kg over 10 min before induction of anesthesia, followed by a continuous infusion of 2 mg/kg/h until the end of the surgery.

Treatment:

Drug: lidocaine

Drug: Sufentanil

Drug: Propofol

Placebo group

Placebo Comparator group

Description:

Patients received a perioperative 0.9% saline infusion at the same rate as the lidocaine infusion.

Treatment:

Drug: 0.9% saline

Drug: Sufentanil

Drug: Propofol