A study to compare the effect of dexmedetomidine versus ketamine in fracture femur patients

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/05/042695
• Lead Sponsor: Nizams Institute of medical sciences Hyderabad India

Brief Summary

This is a prospective randomized controlled trial comparing the effect of dexmedetomidine versus ketamine given intraoperative o postoperative analgesia in fracture femur patients operated under subarachnoid block. Total 75 patients will be recruited with 25 in each group (group dexmedetomidine, group ketamine, control group). The primary outcome is to compare postoperative analgesia and duration of analgesia after fracture femur surgery in dexmedetomidine versus ketamine group and the secondary outcome is to assess cumulative rescue analgesic requirement in different groups, to compare hemodynamic effects, side effects

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-05-19
• Study Start: 2022-05-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1)Patients of either sex 2)Patients with ASA grade 1 and grade 2 3)Patients aged between 18 to 65 years 4)Patients with femur fractures.

Exclusion Criteria

1)Refusal to participate in the study 2)Peripheral neuropathy 3)Patients having coagulation or bleeding abnormalities 4)Local site infection 5)Altered mental status 6)Patients with significant coexisting diseases like ischemic heart disease, impaired renal function and severe liver disease 7)Patients on beta blockers 8)Patients allergic to bupivacaine, dexmedetomidine, ketamine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare postoperative analgesia and duration of analgesia after fracture	1 year
femur surgery in dexmedetomidine versus ketamine group	1 year

Secondary Outcome Measures

Name	Time	Method
cumulative analgesic requirements, hemodynamic effects, side effects	1 year

Trial Locations

Locations (1)

NIZAMS INSTITUTE OF MEDICAL SCIENCES; 🇮🇳 Hyderabad, TELANGANA, India

NIZAMS INSTITUTE OF MEDICAL SCIENCES

🇮🇳Hyderabad, TELANGANA, India

DR RANA ATHER

Principal investigator

8297710738

ranaather9@gmail.com