| CTRI Number |
CTRI/2025/07/090750 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Understanding the Effect of Different Anaesthesia Methods on Post-Surgery Confusion in Elderly Patients |
|
Scientific Title of Study
|
Exploring the effects of Inhalational and intravenous anaesthesia on postoperative delirium in the geriatric population: insights from biomarkers and cognitive assessment |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Omshubham Asai |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Anaesthesiology
1st floor, IPD Building
AIIMS Nagpur, plot no 2, sector-20, MIHAN, Nagpur-441108
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9987154547 |
| Fax |
|
| Email |
omshubham.asai@aiimsnagpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Omshubham Asai |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Anaesthesiology
1st floor, IPD Building
AIIMS Nagpur, plot no 2, sector-20, MIHAN, Nagpur-441108
MAHARASHTRA
441108
India |
| Phone |
9987154547 |
| Fax |
|
| Email |
omshubham.asai@aiimsnagpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Omshubham Asai |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Anaesthesiology
1st floor, IPD Building
AIIMS Nagpur, plot no 2, sector-20, MIHAN, Nagpur-441108
MAHARASHTRA
441108
India |
| Phone |
9987154547 |
| Fax |
|
| Email |
omshubham.asai@aiimsnagpur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Nagpur |
|
|
Primary Sponsor
|
| Name |
AIIMS Nagpur |
| Address |
Plot No. 2, Sector 20, MIHAN, Nagpur (Maharashtra)-441108 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Omshubham Asai |
All India Institute of Medical Sciences, Nagpur |
Plot no 2, sector 20, MIHAN, Nagpur-441108
Nagpur
MAHARASHTRA |
9987154547
omshubham.asai@aiimsnagpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inhalational anesthesia |
All patient will receive opioid free general anaethesia with inj. Midazolam 0.02 – 0.04 mg/kg, Inj. Dexmedetomidine 1mcg/kg infusion for 10 minutes followed by 0.3 - 0.5 mcg/kg/hr infusion, Inj. propofol 1.5 – 2 mg/kg until loss of verbal response. Muscle relaxation will be achieved with Inj. Atracurium 0.5 mg/kg bolus and maintenance with 0.1 mg/kg every 20-30 minutes for surgical anaesthesia. Airway will be secured with appropriate size endotracheal tube and patient will be ventilated with positive pressure-controlled ventilation targeting EtCO2 = 30-40 mm hg. Group I: Anesthesia will be maintained with isoflurane (minimal alveolar concentration 1 to 1.3) and 66 percent air in 33 percent oxygen through a circle system targeting 40 to 60 BIS to prevent intraoperative awareness. |
| Comparator Agent |
Intravenous anesthesia |
All patient will receive opioid free general anaethesia with inj. Midazolam 0.02 – 0.04 mg/kg, Inj. Dexmedetomidine 1mcg/kg infusion for 10 minutes followed by 0.3 - 0.5 mcg/kg/hr infusion, Inj. propofol 1.5 – 2 mg/kg until loss of verbal response. Muscle relaxation will be achieved with Inj. Atracurium 0.5 mg/kg bolus and maintenance with 0.1 mg/kg every 20-30 minutes for surgical anaesthesia. Airway will be secured with appropriate size endotracheal tube and patient will be ventilated with positive pressure-controlled ventilation targeting EtCO2 = 30-40 mm hg. Group T: Anesthesia will be maintained with propofol based TIVA using propofol Infusion at 140 to 200 micrograms per kilograms per minute initially followed by 100 to 140 micrograms per kilograms per minute at 10 minutes and 80 to 120 micrograms per kilograms per minute after 2 hours targeting 40 to 60 BIS to prevent intraoperative awareness. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
ASA I to III posted for elective surgeries requiring general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with a medical history of neurological or neurovascular diseases such as delirium schizophrenia dementia or stroke. Dementia was defined as a Mini-Mental State Examination (MMSE) score of less than 17 for illiterate patients less than 20 for patients with 1 to 6 years of education and less than 24 for patients with 7 or more years of education
Patients who were unable to read or had severe visual or auditory deficits
Patients with a history of alcohol abuse and drug dependence
Patients who were unwilling to comply with the study protocol or procedures.
ASA more than IV
Emergency surgeries
Patients posted for neurosurgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the incidence and severity of postoperative delirium in geriatric patients undergoing general anesthesia in both the group |
day 0 to day 7 postoperatively twice a day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the incidence and severity of postoperative delirium between the two anesthesia techniques. |
Day 0 to day 7 postoperatively twice a day |
| Measure cognitive function preoperatively and postoperatively using the mini mental state examination (MMSE) to assess the impact of anesthesia technique on cognitive outcomes. |
Preoperatively and postoperatively |
| Investigate serum biomarkers S100B and A2M associated with neural damage in the geriatric population to explore potential correlations with anaesthesia technique and postoperative delirium |
preoperatively and postoperative day 1 |
| Analyse the association between cognitive function, serum biomarkers, and the occurrence of postoperative delirium |
at time of data analysis |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background
Postoperative delirium is a common complication among elderly patients undergoing surgery under general anaesthesia. The choice of anaesthetic technique may influence the development of this condition. Inhalational anaesthesia and total intravenous anaesthesia are two standard methods used in general anaesthesia. However, their comparative effects on the incidence of postoperative delirium in elderly patients are not well established. This randomised, double-blinded, controlled trial aims to compare the impact of inhalational anaesthesia and total intravenous anaesthesia on the incidence of postoperative delirium in elderly patients undergoing surgery at a tertiary care centre. The assessment will be done both clinically and through serum biomarkers. Methodology
This is a prospective, randomised, double-blinded, controlled trial involving 80 participants aged 60 years and above, classified as American Society of Anesthesiologists physical status I to III. These patients, scheduled for elective surgery under general anaesthesia, will be randomly assigned to one of two groups. Group I will receive inhalational anaesthesia, and Group T will receive total intravenous anaesthesia. Each group will consist of 40 participants. The incidence and severity of postoperative delirium will be evaluated using the Mini Mental Status Examination preoperatively, and the Confusion Assessment Method Short and Confusion Assessment Method for Intensive Care Unit postoperatively. Serum samples will also be analysed for diagnostic biomarkers of delirium. Statistical analysis will include tests such as Kolmogorov Smirnov test, paired sample t test, analysis of variance, Kruskal Wallis test, Pearson correlation, Fisher exact test, chi square test, and odds ratio. Discussion
The use of anaesthesia is increasing in the elderly surgical population. Postoperative delirium, which is characterised by impaired awareness and attention, can affect up to 60 percent of elderly patients within 24 to 72 hours following surgery. Another related complication is postoperative cognitive dysfunction, which involves persistent cognitive decline after surgery. Inhalational anaesthesia involves the use of volatile agents, while total intravenous anaesthesia with agents like propofol offers benefits such as faster recovery and less postoperative nausea and vomiting. Target controlled infusion provides a precise method for administering intravenous anaesthetics. However, its effects on cognitive outcomes in elderly patients remain uncertain. Recent experimental studies in aged animals with delayed neurocognitive recovery have shown changes in protein expression in brain regions associated with cognition. Dysregulated proteins such as haptoglobin, caseinolytic protease, and alpha two macroglobulin were found to be increased, while levels of 14 three 3 beta alpha and biliverdin reductase A were decreased. These findings were validated using multiple techniques. Similar patterns were observed in serum samples from elderly patients with postoperative delirium and from aged animals with delayed neurocognitive recovery. The altered levels of these proteins may serve as biomarkers for diagnosing postoperative neurocognitive disorders. These findings provide insights into the underlying mechanisms, but the ideal anaesthetic technique for preventing cognitive complications in elderly surgical patients remains unclear. Further research is necessary to determine the most effective anaesthesia strategy in this population.
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