Does lidocaine act as a painkiller during colonoscopy?
Phase 4
Completed
- Conditions
- Healthcare domain: procedural sedation and analgesia (PSA)Surgery
- Registration Number
- ISRCTN47787339
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
2020 Results article in https://doi.org/10.21203/rs.3.rs-50910/v1 (added 22/08/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
1. Colonoscopy performed under PSA
2. Age 18-65 years
3. Inflammatory bowel disease: Crohn’s disease or ulcerative colitis
4. Informed consent
5. ASA classification 1 or 2
Exclusion Criteria
1. Pregnancy
2. Emergency colonoscopy
3. Allergies for study medication
4. Rhythm disorders i.e. first, second or third degree AV block
5. Brugada syndrome
6. Cardiomyopathy
7. BMI >35
8. BMI <18
9. Obstructive sleep apnea syndrome
10. Uncontrolled hypertension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Alfentanyl dose (mcg) required to maintain a score < 4 on the Facial Pain Rating Scale (Wong baker face scale) during the procedure.
- Secondary Outcome Measures
Name Time Method <br> 1. Total propofol dose (mcg) required to maintain sedation level 4-5 on The Ramsey Sedation Scale during the procedure.<br> 2. Infusion time measured in minutes from delivery to end of sedation.<br> 3. Incidence of oxygen desaturation (defined as < 92%) measured continuously during the procedure.<br> 4. Incidence of hypotension (defined as mean arterial pressure < 60 mmHg) measured every 5 minutes during the procedure.<br> 5. Pain score measured using the numerical rating scale after the procedure.<br> 6. Incidence of postprocedural nausea and vomiting measured by patient interview after the procedure.<br> 7. Incidence of adverse effects of lidocaine (e.g. tinnitus, blurred vision or double vision, metal taste during procedure) measured by patient interview after the procedure.<br>