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

NCT05750056 | Completed Phase 4 DMC

• 1 other identifier: K2020-05-029-02
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Recovery

Keywords

endoscopic submucosal dissection; lidocaine; cognitive recovery; quality of recovery

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative cognitive recovery

  Postoperative cognitive recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a multidimensional survey-based tool, which includes a domain designed to measure recovery in the cognitive domain of the PostopQRS over time during the postoperative period. The instrument is administered preoperatively to provide individual baseline measurements for each patient. Tests produce performance scores. Higher scores mean a better outcome. The recovery outcome is defined as returning to at least baseline values.

  Day 3 postoperatively

Secondary Outcomes (11)

• Incidence of postoperative cognitive recovery

  30 minutes after endoscope removal

• Incidence of postoperative cognitive recovery

  Day 1 postoperatively

• Incidence of postoperative cognitive recovery

  Day 7 postoperatively

• Incidence of overall recovery

  30 minutes after endoscope removal

• Incidence of overall recovery

  Day 1 postoperatively

Other Outcomes (3)

• Emergency time

  Immediately after the colonoscopy completely withdrawn

• Patient willingness to recommend screening

  Day 1 postoperatively

• Patient willingness to repeat the procedure

  Day 1 postoperatively

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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.

Drug: lidocaine; Drug: Propofol; Drug: Sufentanil

Placebo group

PLACEBO COMPARATOR

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

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

Interventions

lidocaine 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.

Also known as: Lidocaine IV

Lidocaine group

0.9% saline DRUG

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

Also known as: 0.9% sodium chloride

Placebo group

Propofol 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.

Also known as: Propofol injection

Lidocaine group; Placebo group

Sufentanil DRUG

Sufentail 0.1 ug/kg was administered for sedation induction.

Also known as: Sufentanil injection

Lidocaine group; Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient refuses to participate;
• BMI greater than 30;
• Allergic or contraindication to study drugs;
• History of chronic pain and long-term use of analgesic medication;
• Severe arrhythmia;
• Hepatic and renal dysfunction;

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fujian provincial hospital

Fuzhou, Fujian, China

Location

Related Publications (1)

• Liang Y, Qian B, Zhuo Y, Zhang J, Gao W, Li H, Zhang X, Lin W. Intravenous Lidocaine and Cognitive Recovery After Endoscopic Submucosal Dissection: A Randomized Controlled Trial. Drug Des Devel Ther. 2025 Nov 22;19:10343-10355. doi: 10.2147/DDDT.S557688. eCollection 2025.

  PMID: 41312048 DERIVED

MeSH Terms

Interventions

Lidocaine; Saline Solution; Sodium Chloride; Propofol; Sufentanil

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiaochun Zheng, MD

  Fujian Provincial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: March 1, 2023
• Study Start: February 24, 2023
• Primary Completion: March 29, 2024
• Study Completion: April 5, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: We would like to share our IPD beginning 3 months following the publication of the main results.
• Access Criteria: All of the individual participant data collected during the trial, the study protocol, the statistical analysis plan, and the clinical study report can be accessed with approval from the corresponding author.

Locations

CN (1)