Dose Systemic Lidocaine Improve the Quality of Recovery After Colorectal Endoscopic Submucosal Dissection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: 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.
Other Names:
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.
Other Names:
Drug: Sufentanil
Sufentail 0.1 ug/kg was administered for sedation induction.
Other Names:
|
| Placebo Comparator: Placebo group Patients received a perioperative 0.9% saline infusion at the same rate as the lidocaine infusion. |
Drug: 0.9% saline
Patients received a perioperative saline infusion at the same rate and volume as the lidocaine infusion.
Other Names:
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.
Other Names:
Drug: Sufentanil
Sufentail 0.1 ug/kg was administered for sedation induction.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Incidence of postoperative cognitive recovery [30 minutes after endoscope removal]
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.
- Incidence of postoperative cognitive recovery [Day 1 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.
- 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.
- Incidence of overall recovery [30 minutes after endoscope removal]
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.
- Incidence of overall recovery [Day 1 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.
- Incidence of overall recovery [Day 3 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.
- 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.
- 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).
- 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.
Other Outcome Measures
- Emergency time [Immediately after the colonoscopy completely withdrawn]
Emergency time is defined as the interval from the end of colonoscopy to the MOAA/S score equal to five.
- Patient willingness to recommend screening [Day 1 postoperatively]
Patients will be asked whether they would recommend bronchoscopy screening to a friend or a relative (Yes/No/Unsure).
- Patient willingness to repeat the procedure [Day 1 postoperatively]
Patients will be asked whether they would repeat the identical procedural process (Yes/No/Unsure)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
American Society of Anesthesiologists (ASA) classification I-III;
-
Scheduled for endoscopic colorectal mucosal dissection.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fujian provincial hospital | Fuzhou | Fujian | China |
Sponsors and Collaborators
- Fujian Provincial Hospital
Investigators
- Study Chair: Xiaochun Zheng, MD, Fujian Provincial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K2020-05-029-02