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Comparatively studying the effect of addition of ketamine or magnesium sulphate when added to bupivacaine in scalp block for pain relief in head surgeries.

Comparison of preemptive analgesic efficacy of ketamine versus magnesium sulphate as adjuvant to bupivacaine for scalp block in patients undergoing supratentorial craniotomies: A prospective double blind randomized comparative study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038957
Enrollment
102
Registered
2021-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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: Ketamine addition: 2mg/kg ketamine will be added to 12 ml 0.5 % bupivacaine. The total amount of drug taken will be 18 ml and it will be prepared by adding the normal saline for the rem

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I-III patients in the age group mentioned above with Glasgow coma scale 13-15 who are scheduled for elective supratentorial craniotomies will be included in our study.

Exclusion criteria

Exclusion criteria: Below mentioned are our exclusion criteria: 1. Refusal of consent. 2. Local infection at the injection site 3. Patients with coagulation disorders/thrombocytopenia 4. Patients with Glasgow Coma Scale (GCS) 5. Patients having psychotic disorders/ substance abuse. 6. Patients with poor cognitive functions preoperatively. 7. Patients with chronic headache or on analgesics for long duration. 8. Known or suspected allergy to study drugs. 9. Patients with uncontrolled hypertension, uncontrolled diabetes mellitus or heart disease.

Design outcomes

Primary

MeasureTime frame
Heart rate and mean arterial blood pressure following pin application in supratentorial craniotomies.Timepoint: At 1 minute and 5 minutes following head pin application.

Secondary

MeasureTime frame
Blood sugar levels till 24 hours postoperativelyTimepoint: Baseline after shifting patient to operating table, immediately following induction, 10 min after head pin insertion, end of surgery, at extubation, 2 hours post operatively and 24 hours post operatively;Brain relaxation score following opening of dura mater.Timepoint: At dura mater opening;Critical-Care Pain Observation Tool (CPOT) scoreTimepoint: 1 hour postoperatively, 4 hours postoperatively, 8 hours postoperatively, 16 hours postoperatively and 24 hours postoperatively.;Demand of first analgesic drug intraoperatively( more than 20% increase in heart rate and meaan blood pressure )Timepoint: Time when heart rate and mean blood pressure increase by more than 20% for the first time intraoperatively;Dose of rescue drug like propofol, fentanyl or beta blockers to treat hemodynamic fluctuations(heart rate and mean blood pressure change more than 20% of the baseline)Timepoint: At any time point;Perfusion index values intraoperatively and postoperativelyTimepoint: Baseline after shifting patient to operating table, 1 minute after induction of anesthesia, 5 minutes after induction of anesthesia, during scalp block, 1 minute after scalp block, 5 minutes after scalp block,during head pin application, 1 minute after head pin application, 5 minutes after head pin application,during incision, 1 minute after incision, 5 minutes after incision, every 30 minutes after incision until skin closure, during skin closure;Time of demand for first analgesic drug postoperatively-extubated patients complain of pain and presence of CPOT2 in both extubated and ventilated patientsTimepoint: Time when patient needs analgesia for the first time in post operative period;Total analgesic consumption (opioid/ NSAIDS) intraoperatively and postoperatively up to 24 hours.Timepoint: From entering in operating room upto 24 hours

Countries

India

Contacts

Public ContactDr Sakshi Kadian

AIIMS Rishikesh

priyanka.anaes@aiimsrishikesh.edu.in9811894899

Outcome results

None listed

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