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A clinical trial to evaluate the effects of two drugs, dexmedetomidine and lignocaine, on stress and pain in patients undergoing head surgeries

"Evaluation of Effects of Intravenous Infusion of Dexmedetomidine or Lignocaine on Stress Response and Postoperative Pain in Patients Undergoing Craniotomy for Supratentorial Tumors: A Randomized Controlled Exploratory Study"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044048
Enrollment
105
Registered
2022-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Interventions

Intervention1: Intravenous Dexmedetomidine: patients undergoing supratentorial craniotomy will receive dexmedetomidine bolus infusion of 1 mcg/kg over 15 minutes followed by infusion at the rate of 0.

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1]ASA grade I-II patients 2]Age 18-60 3]GCS score 13-15 4]Patients scheduled for elective supratentorial craniotomy

Exclusion criteria

Exclusion criteria: 1]Refusal of consent 2]Known or suspected allergy to study drug 3]Deranged liver function test and coagulation disorder 4]Poor cognitive function preoperatively 5]Uncontrolled hypertension, diabetes or heart disease 6]Psychotic disorders or substance abuse 7]Chronic headache or on analgesics for long duration 8]2nd and 3rd degree heart block 9]Patients using beta blockers

Design outcomes

Primary

MeasureTime frame
1. Intraoperative hemodynamic variations 2. Response to noxious stimulus of surgery 3. Postoperative pain as evaluated by CPOT Timepoint: 1. Intraoperative 2.postoperative

Secondary

MeasureTime frame
1. Brain relaxation score 2. Incidence of postoperative cognitive dysfunction 3. Quality of recovery scores 4. Effects on extubation criteria Timepoint: 1. intraoperative 2. postoperative

Countries

India

Contacts

Public ContactDr Shivam Shekhar

AIIMS Rishikesh

sanjay.anaes@aiimsrishikesh.edu.in9761712630

Outcome results

None listed

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