A clinical trial is being conducted to investigate the impact of preoperative oral dose of tizanidine on pain after the operation in maxillofacial trauma cases.
Not Applicable
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/10/059108
- Lead Sponsor
- All India Institute of Medical Sciences Patna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients planned for ORIF under general anesthesia for maxillofacial trauma will be included in the study.
1. Age between 18 and 65 years
2. ASA-PS Grade 1 & 2
3. BMI <30kg/m2
Exclusion Criteria
1. Patient refusal to participate in the study
2. Patients with known hypersensitivity to study medications.
3. Patients with renal or hepatic insufficiency
4. Patients on anti-hypertensive drugs, sedatives or alpha-2 agonists
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of tizanidine as a premedication on post-operative pain relief, as measured by the visual analog scale (VAS), in patients undergoing open reduction and internal fixation (ORIF) for maxillofacial trauma under general anesthesia.Timepoint: Postoperative period at 24 hours
- Secondary Outcome Measures
Name Time Method - To evaluate the requirement of rescue analgesic <br/ ><br>- To evaluate post-operative sedation <br/ ><br>- To monitor and evaluate haemodynamic parameters-heart rate (HR) and mean arterial pressure (MAP) <br/ ><br>- To assess incidence of PONVTimepoint: post-operative period at the intervals of 2, 6, 12 and 24 hours