Trial to evaluate the analgesic effect of dexmedetomidine infusion in robotic onco surgeries.

Randomised controlled trial to evaluate the peri-operative analgesic effect of intra-operative dexmedetomidine infusion in robotic assisted laparoscopic onco- surgeries.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/08/006130

Enrollment

Registered

2015-08-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Dexmedetomidine infusion in the intra-operative period: Dexmedetomidine infusion will be assessed for hemodynamic stability and fentanyl reducing property with respect to placebo ( sali

Eligibility

Inclusion criteria

Inclusion criteria: ASA I-II patients posted for robot assisted laparoscopic surgery.

Exclusion criteria

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 • 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.

Design outcomes

Primary

Measure	Time frame
â?¢ Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries. â?¢ Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement) Timepoint: â?¢ Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries. â?¢ Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement)	—

Measure

Time frame

â?¢ Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries. â?¢ Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement) Timepoint: â?¢ Reduction in intraoperative opioids requirement by using dexmedetomidine iv infusion verses saline in robotic assisted laproscopic onco surgeries. â?¢ Time to need for first rescue analgesic in postoperative period (PS3/10. At rest/ 4/10 at movement)

—

Secondary

Measure	Time frame
Â· To compare intra-operative hemodynamics 5, 10, 20 ,and every 30 min till stop of infusion Â· To compare no of episodes of hypotension / bradycardia Â· Recovery time-time to eye opening after switching off of inhalational agents (i.e. inspiratory inhalational agent- zero ) Â· Incidence of Postoperative nausea and vomiting in either groupTimepoint: Intraoperative and first 24 hours	—

Countries

India

Contacts

Public ContactDr Sumitra G Bakshi

Department of Anesthesia, Critical Care and Pain

sumitrabakshi@yahoo.in91-22-4177058

Outcome results