Clinical trial NCT05750056: Dose Systemic Lidocaine Improve the Quality of Recovery After Colorectal Endoscopic Submucosal Dissection
Official title: Effect of Intraoperative Intravenous Lidocaine on the Quality of Recovery Following Colorectal Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Recovery
Keywords: endoscopic submucosal dissection
lidocaine
cognitive recovery
quality of recovery
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of postoperative cognitive recovery
timeFrame: Day 3 postoperatively
Secondary outcomes:
measure: Incidence of postoperative cognitive recovery
timeFrame: 30 minutes after endoscope removal
measure: Incidence of postoperative cognitive recovery
timeFrame: Day 1 postoperatively
measure: Incidence of postoperative cognitive recovery
timeFrame: Day 7 postoperatively
measure: Incidence of overall recovery
timeFrame: 30 minutes after endoscope removal
measure: Incidence of overall recovery
timeFrame: Day 1 postoperatively
measure: Incidence of overall recovery
timeFrame: Day 3 postoperatively
measure: Incidence of overall recovery
timeFrame: Day 7 postoperatively
measure: Propofol consumption
timeFrame: During the colonoscopy procedure
measure: Endoscopitst satisfacrion
timeFrame: At completion of colonoscopy procedure
measure: Patient satisfaction
timeFrame: On 1 day postoperatively
measure: Incidence of adverse events
timeFrame: Up to 24 hours postoperatively
Other outcomes:
measure: Emergency time
timeFrame: Immediately after the colonoscopy completely withdrawn
measure: Patient willingness to recommend screening
timeFrame: Day 1 postoperatively
measure: Patient willingness to repeat the procedure
timeFrame: Day 1 postoperatively
Locations:
city: Fuzhou
country: China
facility: Fujian provincial hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Xiaochun Zheng, MD
role: STUDY_CHAIR
References: