Trial to evaluate the analgesic effect of dexmedetomidine infusion in robotic onco surgeries.
- Conditions
- All patients planned for robotic onco surgeries
- Registration Number
- CTRI/2015/08/006130
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Robotic assisted surgery has become widespread in a variety of operations. Intra-operative management of these cases is challenging to the anesthesiologists. Pneumoperitoneum and carbon dioxide insufflations lead to sympathetic response. Dexmedetomidine ( dexem) due to its distinct properties can be used as adjuvant analgesic in the form of intravenous infusion. We plan to study the use of dexem in robotic surgeries and evaluate its effect in hemodynamcis, analgesics, and anesthetic requirement.
46 ASA I-II patients planned to undergo robotic oncosurgeries will be included. After induction of general anesthesia, an independent group will randomize patient as per computer generated sheets and prepare study drug and handover the drug to the investigator. The study drug infusion will be started five minutes after insufflation of the abdomen.The initial bolus of dexem 1ug/kg and maintenance of 0.2 ug/kg/hr will be based on standard preparation of drug 2ug/ml. In the saline group equivalent amount of saline will be infused at that rate. The infusion will be stopped at the release of pnuemoperitonuem. All port sites will be infiltrated with local anesthetics.time to eye opening will be noted after reversal as per standard protocol.
In the Post anesthetia care unit, patient will be reassessed after an hour for pain scores . At any point of time if pain at rest is more than 3 or at movement more than 4 - rescue analgesic will be administered as per protocol and time noted.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 46
ASA I-II patients posted for robot assisted laparoscopic surgery.
- •Contraindication to the use of dexmedetomidine- c/o liver dysfunction- cirrhotic or pt with deranged LFT- e.g. Alanine transaminase（ALT）and (or) Aspartate aminotransferase（AST） 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 •Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement) •Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries. | •Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement) •Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries. •Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries. | •Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement)
- Secondary Outcome Measures
Name Time Method · To compare intra-operative hemodynamics 5, 10, 20 ,and every 30 min till stop of infusion · To compare no of episodes of hypotension / bradycardia
Trial Locations
- Locations (1)
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Tata Memorial Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Sumitra G BakshiPrincipal investigator22-24309683sumitrabakshi@yahoo.in