Dose Systemic Lidocaine Improve the Quality of Recovery After Colorectal Endoscopic Submucosal Dissection
- Conditions
- Postoperative Recovery
- Interventions
- Registration Number
- NCT05750056
- Lead Sponsor
- Fujian Provincial Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- American Society of Anesthesiologists (ASA) classification I-III;
- Scheduled for endoscopic colorectal mucosal dissection.
- 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;
- Any other conditions precluded study inclusion, such as cognitive impairment, pregnancy, or inability to communicate in Mandarin Chinese.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group 0.9% saline Patients received a perioperative 0.9% saline infusion at the same rate as the lidocaine infusion. Lidocaine group 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 surgery. Placebo group Propofol Patients received a perioperative 0.9% saline infusion at the same rate as the lidocaine infusion. Lidocaine group Propofol 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. Lidocaine group Sufentanil 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. Placebo group Sufentanil Patients received a perioperative 0.9% saline infusion at the same rate as the lidocaine infusion.
- Primary Outcome Measures
Name Time Method Incidence of postoperative cognitive recovery Day 3 postoperatively 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.
- Secondary Outcome Measures
Name Time Method Incidence of overall recovery Day 7 postoperatively The Postoperative Quality of Recovery Scale (PostopQRS) is a multidimensional survey-based tool, which contains physiological, emotive, nociceptive, activities of daily living, and cognitive recovery over time. Nociceptive, emotive, and activities of daily living that can be scored in a categorical fashion. In the cognitive domain, tasks receive a performance score. In the physiologic domain, values are transformed and categorized as acceptable, somewhat or far outside of the desirable boundaries, based on normative population data. Higher scores mean a better outcome, except for nociceptive domain. Overall recovery is postoperative values equaling or exceeding individual baseline values in each of the domains of the PostopQRS. The incidence of recovery is expressed as a percentage of participants recovered/group total at each time point.
Propofol consumption During the colonoscopy procedure Propofol consumption will be recorded during the colonoscopy procedure.
Incidence of postoperative cognitive recovery Day 7 postoperatively 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.
Patient satisfaction On 1 day postoperatively Patient satisfaction will be evaluated using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).
Incidence of adverse events Up to 24 hours postoperatively Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial.
Endoscopitst satisfacrion At completion of colonoscopy procedure Endoscopitst satisfacrion will be evaluated using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).
Trial Locations
- Locations (1)
Fujian provincial hospital
🇨🇳Fuzhou, Fujian, China