Opioid Free Anaesthesia For Brain Surgery

Not yet recruiting

Conditions: Malignant neoplasm of cerebrum, except lobes and ventricles,

Registration Number: CTRI/2022/08/044598

Lead Sponsor: AIIMS

Brief Summary: In the preoperative period, a written, informed consent will be obtained from patients meeting the inclusion criteria after detailed explanation of study.Patients will either receive fentanyl @2mcg/kg at induction followed by 1mcg/kg/hr for maintainance (Group F) or Dexmedetomidine bolus@1mcg/kg over 10min before induction followed by 0.2 to 0.7mcg/kg/hr and scalp block with ropivacaine (0.25%) after induction of anaesthesia (Group DS). Propofol 1.5 to 2mg/kg will be used for induction of anaesthesia. Tracheal intubation with cuffed portex tube will be facilitated with rocuronium 1mg/kg.Both the groups will receive skin infiltration with lignociane 2% (3-5ml) for skull pin insertion. Anaesthesia will be maintained with air/oxygen mixture (1:1) at flow rate of 2lt/min.Propofol infusion at 100 to 150mcg/kg/min will be used for mainatinace intaop. Intraoperative nuromuscular blockade will be maintained with rocuronium 0.2 to 0.3mg/kg/hr infusion. fentanyl and rocuronium infusion will be stopped at start of dural closure. in group DS, dexmedetomidine infusion will be stopped at start of skin closure. for both groups propofol infusion will be stopped at start of skin closure. Patients in both groups will receive IV paracetamol 0.15gm/kg and ondansetrone 0.1mg/kg at start of skin closure. emergence and extubation times will be recorded in both groups after reversal agents are given at end of procedure. Quality of emergence by RAAS will be noted during emergence, at 10min and 4hrs post extubation. Patients hemodynamics will be monitored from preinduction (baseline), intraop, postop in ICU. Pain will be assessed using NRS scale in OT and 4,6,12,24 hrs in ICU. Duration of ICU stay and hospital stay will be recorded.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 44

Inclusion Criteria

1.Written informed consent 2.Undergoing craniotomy for elective supratentorial tumour excisions, size <4 cm in any dimensions.
3.American Society of Anesthesiologists class I&II.

Exclusion Criteria

1.Patientâ€™s refusal 2.Anticipated difficult airway/ intubation including those with cervical spine disease.
3.Pregnancy 4.Body mass index of > 35 kg/m2 5.Patients who had sensitivity to opioids, dexmedetomidine, ropivacaine (study drugs) 6.Patients with cardiovascular diseases or respiratory diseases 7.Previous history of craniotomy or any intracranial procedure.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Extubation time (in minutes)	At emergence and extubation
1.Emergence time (in minutes)	At emergence and extubation
Primary: To compare opioid free anesthetic technique with conventional opioid based anesthetic technique in terms of emergence from anaesthesia in patients undergoing elective supratentorial craniotomy.	At emergence and extubation

Secondary Outcome Measures

Name	Time	Method
1.Intraoperative Hemodynamic response, such as heart rate and mean art. Pressure.	2.Rate of Post operative nausea vomiting [PONV]

Trial Locations

Locations (1): AIIMS New Delhi
🇮🇳
South, DELHI, India
AIIMS New Delhi
🇮🇳South, DELHI, India
Dr Davinder Jit Singh
Principal investigator
8728055241
davinderjit98@gmail.com