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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.

Comparison of effects of intravenous infusion of dexmedetomidine versus low dose ketamine- dexmedetomidine combination on spinal block, surgical stress response and discharge readiness from pacu in orthopedic patients- a prospective, randomized controlled clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033549
Enrollment
60
Registered
2021-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: S823- Fracture of lower end of tibia Health Condition 2: S822- Fracture of shaft of tibia Health Condition 3: S821- Fracture of upper end of tibia Health Condition 4: S729- Unspecified fracture of femur

Interventions

Intervention1: Group B-Low dose Ketamine and Dexmedetomidine infusion : Group B Bolus- Dexmedetomidine 0.5mcg/kg over 10 min and Ketamine 0.2mg/kg over 2-3 min Maintenanace- ketamine 0.2mg/kg/hr and

Sponsors

Annapureddy Sai Krishna Reddy
Lead Sponsor

Eligibility

Inclusion criteria

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

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. 7.Surgeries having a duration of less than 1.5 hours and more than 4 hours. 8.Patients requiring supplementation with general anaesthetic agents.

Design outcomes

Secondary

MeasureTime frame
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. 3.To compare the readiness of discharge from the PACU between the two groups.Timepoint: 1. Every 5 minutes intraoperatively. 2. At 6 hours and 24 hours from end of surgery. 3. Every 5 minutes postoperative in PACU till modified Aldrete score 9 or more is achieved with sensory level of T10.—

Primary

MeasureTime frame
To compare the time of regression of sensory blockade to S1 between the two groupsTimepoint: Every 30 minutes postoperative till regression to S1 is achieved—

Countries

India

Contacts

Public ContactAnnapureddy Sai Krishna Reddy

Hamdard Institute of Medical Sciences and Research

jyotsna.doctor@gmail.com7780513341

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026