Comparing the benefits of 2 medicines (dexmedetomidine versus ketamine- dexmedetomidine combination) on spinal block in extending the duration of pain relief, reduction in surgical stress and early discharge from recovery room to ward in patients undergoing orthopedic surgery.

Completed

Conditions: Unspecified fracture of femur, (2) ICD-10 Condition: S821||Fracture of upper end of tibia, (3) ICD-10 Condition: S822||Fracture of shaft of tibia, (4) ICD-10 Condition: S823||Fracture of lower end of tibia,

Registration Number: CTRI/2021/05/033549

Lead Sponsor: Annapureddy Sai Krishna Reddy

Brief Summary: We will be comparing the effects of intravenous infusion of Dexmedetomidine versus low dose Ketamine & Dexmedetomidine infusion on spinal block in lower limb orthopedic surgeries titrating the dose of Dexmedetomidine to maintain a Ramsay sedation score of 3-4. Patients will be selected based on the inclusion and exclusion criteria as mentioned above. Statistical analysis will be performed by using SPSS statistical software version 22.0 and R.3.2.0 and results will be tabulated in a Microsoft Office Excel worksheet. T-test will be used for comparing the parameters between the groups. This study helps in identifying whether low dose ketamine-dexmedetomidine combination is superior to dexmedetomidine alone in managing postoperative analgesia and hemodynamic stability in orthopedic surgeries under spinal anaesthesia. There are no studies on intravenous ketamine-dexmedetomidine combination in patients under spinal anaesthesia. If proven effective, the combination of dexmedetomidine-ketamine can be very useful in reducing patient length of stay in PACU and reduce hospital costs.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

All patients of age 18-65 years, BMI 18-30 having an ASA physical status of either 1 or 2, posted for elective orthopedic lower limb surgeries under spinal anaesthesia will be included in this study.

Exclusion Criteria

1.Patients with prior addiction or analgesic abuse (opioid and non-steroidal anti-inflammatory drug medications).
2.Patients with a history of psychiatric or neurological disease, deafness.
3.Patients who do not achieve a sensory level of T10 or above.
4.Patients who do not achieve Modified Bromage scale of 1-2.
5.Patients complaining of pain within 60 minutes of the start of surgery.
6.Patients with difficult spinal requiring more than 3 attempts.
8.Patients requiring supplementation with general anaesthetic agents.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the time of regression of sensory blockade to S1 between the two groups	Every 30 minutes postoperative till regression to S1 is achieved

Secondary Outcome Measures

Name	Time	Method
1.To compare the intraoperative hemodynamic stability between the two groups.	2.To compare the change in perioperative stress markers in preoperative and postoperative period between the two groups.

Trial Locations

Locations (1): Hamdard Institute of Medical Sciences and Research, New delhi 110062
🇮🇳
South, DELHI, India
Hamdard Institute of Medical Sciences and Research, New delhi 110062
🇮🇳South, DELHI, India
Annapureddy Sai Krishna Reddy
Principal investigator
7780513341
saikrishnaannapureddy@gmail.com