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A study to see whether a medicine given as a tablet is as effective in reducing the blood pressure compared to another medicine given as injection in patients who need back surgery. Both medicines reduce blood pressure and may reduce blood loss.

Randomized controlled study comparing the efficacy of oral Clonidine and intravenous Dexmedetomidine in maintaining the hemodynamic stability in patients undergoing major spine surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042101
Enrollment
75
Registered
2022-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Intravenous Dexmedetomidine 0.5microgram/kg/hour after turning the patient prone for surgery.: Patients in this arm receive Tab Diazepam 10 mg as a placebo for blinding purposes and rec

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA physical status 1 and 2 2. 2 or more level spine instrumentation

Exclusion criteria

Exclusion criteria: 1. ASA physical status 3 and 4 2. Patients on Chronic Beta blocker therapy 3. Patients with uncontrolled blood pressure 4. Patients with renal or liver disease 5. Patients on ACE inhibitors/ ARBs

Design outcomes

Primary

MeasureTime frame
Measurement of Systolic, diastolic and mean blood pressures during surgery. Heart rate, number of episodes of hypotension and hypertension will also be recordedTimepoint: Recordings will be baseline before intubation, after intubation, after proning the patient and every 15 minutes till end of surgery.

Secondary

MeasureTime frame
1. To compare intraoperative analgesic requirements, blood loss and recovery time from anesthesiaTimepoint: Total dose of fentanyl and propofol needed during surgery and blood loss at the end of surgery will be calculated. All measurements will be completed by the end of surgery

Countries

India

Contacts

Public ContactKrishnan B S

Sri Narayani Hospital and Research Centre

b_s_krishnan@hotmail.com6380546634

Outcome results

None listed

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