Comparing anaesthesia given through veins and anaesthesia given through lungs for post operative confusion and memory loss

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/03/032265
• Lead Sponsor: SCTIMST fluid research grant

Brief Summary

Itwill be a prospective randomized double blinded interventional study. Afterapproval from the IEC and getting informed consent 80 consecutive patientsundergoing CABG or Aortic valve replacement for Aortic stenosis will berandomly allocated to receive either inhalation anaesthesia or Totalintravenous anaesthesia. Computer generated random table will be used toallocate subjects to one of the study groups. Sequentially numbered sealedopaque envelopes will contain the treatment code, to be opened in the morningof surgery. Patients and the principal investigator will be unaware of groupassignment. All the statistical analyses will be performed by thebiostatistician not involved in treatment allocation. Standard anaesthesiainduction and intubation will be done using fentanyl 5-10 mcg/kg, midazolam0.05-0.1 mg/kg, propofol sleep dose upto 2mg/kg and pancuronium 0.1mg/kg.Fentanylinfusion will be started at 2mcg/kg/hr. Total upto 20 mcg/kg fentanyl will begiven prior to sternotomy. Baseline demographics of all the patients includingage, sex, height,weight, BMI,comorbidities and type of surgery will be noted .Baseline Montreal cognitiveassessment score will be assessed the day before surgery. All standard ASAmonitoring will be done. Additionally Bispectral index monitoring will be doneto ensure adequate depth of anaesthesia and maintained at < 60. Near-infraredspectroscopy to record cerebral oximetry and TEE for regular cardiac evaluationand to look for atheroma and its grade will be used. Patients in the Total intravenous anaesthesia groupwill receive propofol titrated to Bispectral index for maintenance along withfentanyl infusion during cardiopulmonary bypass while the patients in the Inhalational group will receivesevoflurane titrated to Bispectral index along with fentanyl infusion formaintenance on CPB. The depth ofanaesthesia will be monitored andmaintained in both the groups usingBispectral index monitor. All patients will bescreened for presence of atheromatous plaque in the aorta and the Katz grading will be noted.. The MAP will be maintained above 60mm Hg till institutionof CPB .PaCO2 will be maintained at 35-45 mmHg. CPB will be instituted and maintained as perstandard protocol. NIRS values will be recordedat various time intervals: baseline,intubation, after going on CPB,after cross-clamping, at lowest temperature, during warming at 36°C,post-bypass and after skin closure. MAP on CPB will be maintained more than 50 mmHg andthe haematocrit more than 21%.Other parameters recorded will beduration of CPB, cross clamp time and intraoperative glucose levels. In the ICUtime to extubation readiness will be noted. Dexmedetomidine infusion forsedation at 0.1 -0.3 mcg/kg /hr will be started for all patients on arrival tothe ICU and continued for 24 hrs with fentanyl infusion at 1mcg/kg/hr. Allpatients will receive 6th hourly IV paracetamol for post-operativeanalgesia. Postoperative delirium(time frame: 2 days after surgery) detectionwill be managed with Confusion Assessment Method for the ICU (CAM-ICU) on POD1and 2.Delerium will be managed with quetiapine or haloperidol as perintensivist order. Early postoperative cognitive dysfunction (Time Frame: 7days after surgery )we will use Montreal Cognitive Assessment (MoCA) to detectcognitive dysfunction

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Inclusion criteria: 1.Age from 18 -80 yrs 2.Undergoing CABG or Aortic valve surgery for Aortic stenosis on CPB 3.Consenting for the study.

Exclusion Criteria

emegency surgery, poor language comprehension, neurologic disorders, allergy to anaesthetic agent,significant carotid artery stenosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Compare the incidence of early postoperative delirium on post opeative day 1 and 2 in both the groups	1.Compare the incidence of early postoperative delirium in both the groups on post operative days 1 and 2 | 2.Compare the cerebral oxygen saturation in both the groups baseline before induction,after intubation induction,immediately after | going on cardiopulmonary bypass,after aortic cross clamp,at moderate hypothermia(28°c),during rewarming,after cpb and after sternal closure
2.Compare the cerebral oxygen saturation in both the groups	1.Compare the incidence of early postoperative delirium in both the groups on post operative days 1 and 2 | 2.Compare the cerebral oxygen saturation in both the groups baseline before induction,after intubation induction,immediately after | going on cardiopulmonary bypass,after aortic cross clamp,at moderate hypothermia(28°c),during rewarming,after cpb and after sternal closure

Secondary Outcome Measures

Name	Time	Method
1.Intraoperative glycaemic control in both the groups	2.Analyse the Katz 3-5 atherosclerosis in the patients with post op delirium.

Trial Locations

Locations (1)

Sree Chithira Thirunal Institute of Medical science and technology; 🇮🇳 Thiruvananthapuram, KERALA, India

Sree Chithira Thirunal Institute of Medical science and technology

🇮🇳Thiruvananthapuram, KERALA, India

Dr Unnikrishnan KP

Principal investigator

9446177521

unnikp@gmail.com