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A study to know efficacy of addition of ketamine to bupivacaine for scalp block to minimize head pin response in patients undergoing brain surgery

Efficacy of ketamine as an adjuvant to bupivacaine for scalp block to minimize head pin response in patients undergoing supratentorial surgery: A prospective double blind randomized control study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022165
Enrollment
60
Registered
2019-11-27
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: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: Efficacy of ketamine as an adjuvant to bupivacaine for scalp block to minimize head pin response in patients undergoing supratentorial surgery: atients meeting inclusion criteria will b

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 ASA 1&2 patients aged 18-65 years. 2 Scheduled for elective supratentorial craniotomy surgery

Exclusion criteria

Exclusion criteria: 1 Refusal of consent. 2 Patients with Glasgow Coma Scale (GCS) 3 Patients having psychotic disorders. 4 Patients with poor cognitive functions preoperatively or postoperatively. 5 Patients intended for postoperative mechanical ventilation or not extubated at the time of surgery. 6 Patients require reintubation during study period. 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 D.M or heart disease.

Design outcomes

Primary

MeasureTime frame
Primary outcome Record of HR & MAP at the time of head pinning in both groups. Secondary outcomes 1. objective assessment of brain relaxation following opening of dura 2. Duration of analgesia (Request for first analgesia or NRS 4) 3. Total Analgesic consumption in intraoperative and postoperative period till 24 hours. 4. Numerical Rating Scale (NRS) pain score at various time points in postoperative period till 24 hours. Timepoint: Systolic arterial pressure, diastolic arterial pressure, mean arterial pressure (MAP), heart rate (HR) will be recorded at baseline , 1 min and 5 min after induction of anaesthesia, during, 1 min and 5 min after the scalp block, during, 1 min and 5 min after the head pinning, during , 1 min, 5 min and then every 30 mnts after the incision till skin closure, and during, 1 min and 5 min after skin closure.

Secondary

MeasureTime frame
1. objective assessment of brain relaxation following opening of dura 2. Duration of analgesia (Request for first analgesia or NRS 4) 3. Total Analgesic consumption in intraoperative and postoperative period till 24 hours. 4. Numerical Rating Scale (NRS) pain score at various time points in postoperative period till 24 hours. Timepoint: Patientsâ?? severity of pain will be assessed just after extubation, followed by 1, 2, 4, 8, 16, and 24 hours post-extubation with the help of NRS score.

Countries

India

Contacts

Public ContactAshutosh kaushal

AIIMS, Rishikesh

drashutosh.kaushal@gmail.com9599156154

Outcome results

None listed

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