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

NCT ID: NCT05750056

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-24
• Study Completion Date: 2024-04-05

Brief Summary

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.

Detailed 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.

Conditions

Postoperative Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine group

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.

Group Type: EXPERIMENTAL

lidocaine

Intervention Type: DRUG

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 procedure.

Propofol

Intervention Type: DRUG

An i.v. bolus injection of propofol 1 mg/kg was given to all patients. Propofol was then titrated if necessary to produce unconsciousness during the introduction of the endoscope. Afterward, the anesthesiologist determined the dose of propofol and titrated to effect.

Sufentanil

Intervention Type: DRUG

Sufentail 0.1 ug/kg was administered for sedation induction.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

0.9% saline

Intervention Type: DRUG

Patients received a perioperative saline infusion at the same rate and volume as the lidocaine infusion.

Propofol

Intervention Type: DRUG

An i.v. bolus injection of propofol 1 mg/kg was given to all patients. Propofol was then titrated if necessary to produce unconsciousness during the introduction of the endoscope. Afterward, the anesthesiologist determined the dose of propofol and titrated to effect.

Sufentanil

Intervention Type: DRUG

Sufentail 0.1 ug/kg was administered for sedation induction.

Interventions

lidocaine

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 procedure.

Intervention Type: DRUG

0.9% saline

Patients received a perioperative saline infusion at the same rate and volume as the lidocaine infusion.

Intervention Type: DRUG

Propofol

An i.v. bolus injection of propofol 1 mg/kg was given to all patients. Propofol was then titrated if necessary to produce unconsciousness during the introduction of the endoscope. Afterward, the anesthesiologist determined the dose of propofol and titrated to effect.

Intervention Type: DRUG

Sufentanil

Sufentail 0.1 ug/kg was administered for sedation induction.

Intervention Type: DRUG

Other Intervention Names

Lidocaine IV; 0.9% sodium chloride; Propofol injection; Sufentanil injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Provincial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yao Yusheng

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaochun Zheng, MD

Role: STUDY_CHAIR

Fujian Provincial Hospital

Locations

Fujian provincial hospital

Fuzhou, Fujian, China

Countries

China

Other Identifiers

K2020-05-029-02

Identifier Type: -

Identifier Source: org_study_id