Trial to evaluate the analgesic effect of dexmedetomidine infusion in robotic onco surgeries.
Phase 4
- Registration Number
- CTRI/2015/08/006130
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
ASA I-II patients posted for robot assisted laparoscopic surgery.
Exclusion Criteria
•Contraindication to the use of dexmedetomidine- c/o liver dysfunction- cirrhotic or pt with deranged LFT- e.g. Alanine transaminaseï¼?ALTï¼?and (or) Aspartate aminotransferaseï¼?ASTï¼? level is more than twice the upper limit of normal, INR >1.5
•Patient with severe renal dysfunction, GFR less than 50 ml /hr
•All hypertensives,
•Patients with heart blocks or bradycardia HR <60,
•Patient with premature ventricular ectopics >5/min.
•Mini laparotomy( more than 5 cm ) planned for removal for anastomosis or surgical dissection e.g, robotic assisted cystectomy, whipples surgery, abdominal perineal resection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries. <br/ ><br>â?¢Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement) <br/ ><br>Timepoint: â?¢Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries. <br/ ><br>â?¢Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement) <br/ ><br>
- Secondary Outcome Measures
Name Time Method · To compare intra-operative hemodynamics 5, 10, 20 ,and every 30 min till stop of infusion <br/ ><br>· To compare no of episodes of hypotension / bradycardia <br/ ><br>· Recovery time-time to eye opening after switching off of inhalational agents (i.e. inspiratory inhalational agent- zero ) <br/ ><br>· Incidence of Postoperative nausea and vomiting in either groupTimepoint: Intraoperative and first 24 hours