A clinical trial to study the effect of two methods of anesthesia, total intravenous anesthesia and inhalational anesthesia on neuroinflammation

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/10/058436
• Lead Sponsor: Sree Chitra Thirunal Institute of Medical Sciences and Technology

Brief Summary

This study intends to evaluate which anaesthetic technique, propofol-based total intravenous anesthesia or sevoflurane-based inhalational anesthesia has a better neuronal and systemic anti-inflammatory profile. Glioma is a disease state with a high risk of morbidity and mortality. Thus, identifying the ideal anaesthetic agent will provide a better neurophysiological profile by suppressing neuronal and systemic inflammation in the perioperative period. A prospective randomized controlled  trial will be done to evaluate the inflammatory markers in patients undergoing craniotomy for supratentorial glioma under propofol-based intravenous anaesthesia and sevoflurane-based inhalational anesthesia

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-10
• Study Start: 2023-12-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patient consent 2) ASA class I-II 3)Age 18-65 years, undergoing craniotomy for supratentorial glioma in the neurosurgery operation theatre 4)Preoperative Karnofsky Performance Scale of 70 or above.

Exclusion Criteria

• 1. ASA class III,IV, V 2) Severe or uncompensated cardiovascular, renal, hepatic or endocrine disease 3) Pregnancy, postpartum and lactating females 4) Drug allergy to Propofol 5) Refusal to consent by patient or next of kin •patients with an active inflammatory process such as infection or immunologic illness known to increase the baseline immunologic markers, •Emergency surgery •Revision craniotomy at the same site •Preoperative history of seizures.
• • h/o preoperative cognitive dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Changes in the blood level of neuron specific enolase measured before induction of anesthesia & at the end of surgery	Before induction of anesthesia & after extubation
2.Changes in the blood level of interleukin -6 measured before the induction of anesthesia & at the end of surgery	Before induction of anesthesia & after extubation

Secondary Outcome Measures

Name	Time	Method
Hemodynamic parameters- heart rate & invasive blood pressure, urine output, maximum allowable blood loss, estimated blood loss, & total fluid input.	1)Tumour type, size, location, grade of tumor, duration of surgery, duration of anaesthesia, days of ICU stay, and days of hospital stay.

Trial Locations

Locations (1)

SREE CHITRA THIRUNAL INSTITUTE OF TECHNOLOGY; 🇮🇳 Thiruvananthapuram, KERALA, India

SREE CHITRA THIRUNAL INSTITUTE OF TECHNOLOGY

🇮🇳Thiruvananthapuram, KERALA, India

DR AJAY PRASAD HRISHI

Principal investigator

7012581920

drajay@sctimst.ac.in