| CTRI Number |
CTRI/2025/07/090809 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Sevoflurane vs Desflurane in Spine surgery patients on cognition in the post-operative period.
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Scientific Title of Study
|
Comparison of sevoflurane and desflurane for post-operative neurocognitive dysfunction in patients undergoing spine surgeries : A prospective randomized controlled close- ended assessor blinded clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayank Sharma |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NAGPUR |
| Address |
OT complex, Department of Anaesthesiology, first floor, AIIMS Nagpur,Mihan,Nagpur
MAHARASHTRA
441108
India |
| Phone |
9079950826 |
| Fax |
|
| Email |
mayank25150524@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gajanan N Chavan |
| Designation |
Professor and Head |
| Affiliation |
AIIMS NAGPUR |
| Address |
HOD office,Department of Anesthesiology, first floor, AIIMS NAGPUR, MIHAN
Nagpur
MAHARASHTRA
441108
India |
| Phone |
07694014955 |
| Fax |
|
| Email |
santosh72@aiimsnagpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mayank Sharma |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NAGPUR |
| Address |
OT complex,Department of Anesthesiology, first floor, AIIMS NAGPUR, Mihan
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9079950826 |
| Fax |
|
| Email |
mayank25150524@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
SELF |
| Address |
AIIMS NAGPUR, CHARAK HOSTEL |
| Type of Sponsor |
Other [] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mayank Sharma |
AIIMS Nagpur |
Department of Anesthesia, OT complex,room number-1, Departments office.
Nagpur
MAHARASHTRA |
9079950826
mayank25150524@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS NAGPUR IEC |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DESFLURANE |
This study aims to compare the effects of sevoflurane and desflurane on post-operative cognitive dysfunction (POCD) in young adults undergoing spine surgery. POCD is a temporary cognitive decline following surgery, characterized by impairments in memory, attention, and executive function.
The dose will be 4-6 percent to maintain a MAC of 0.8-1 via inhalational route from induction till before extubation as a maintenance agent. |
| Comparator Agent |
SEVOFLURANE |
This study aims to compare the effects of sevoflurane and desflurane on post-operative cognitive dysfunction (POCD) in young adults undergoing spine surgery. POCD is a temporary cognitive decline following surgery, characterized by impairments in memory, attention, and executive function.The dose will be 1-2 percent to maintain a MAC of 0.8-1 via inhalational route from induction till before extubation as a maintenance agent. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Age-young and middle aged adults
ASA 1 and 2
Surgery of lumbar or thoracic spine surgery
Level of education_at least till high school
Preop MMSE greater than or equal to 23
Absence of serious hearing or vision impairment |
|
| ExclusionCriteria |
| Details |
Known cases of dementia or any psychiatric illness
History of CVA with residual deficit
Alcoholism , drug dependence
Current use of benzodiazepine, antidepressants or psychotropic drugs
Contraindication to use of inhalational agents
Emergency nature of surgery
Perioperative complications- requirements of post op ventilation, hemodynamic instability. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of POCD Assessed using a validated battery of neuropsychological tests administered preoperatively baseline (24 hrs prior) and postoperatively e.g postoperative day 7 and day 30. POCD is defined as a significant decline in cognitive test performance compared to baseline. The primary comparison is between the sevoflurane group and the desflurane group to evaluate the impact of the anesthetic agent on cognitive outcomes. |
preoperatively (24 hrs), post-op day 7, post op day 30. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Change in MoCA Score
Difference in MoCA scores from baseline to postoperative will be calculated to assess cognitive decline & compare between groups
Association Between rSO2 & POCD
Intraoperative rSO2 monitored using NIRS
Correlation analysis between rSO2 values & incidence or severity of POCD in both groups
Intraoperative Hemodynamic Parameters
Heart rate mean arterial pressure MAP & oxygen saturation recorded at fixed intervals
Compared between groups to assess physiological stability of each anesthetic
Recovery Profile
Time to eye opening extubation & orientation recorded
Compared between groups to evaluate recovery & emergence
|
24hrs pre op
7 days post op
30 days post op |
|
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Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
COMPARISON OF SEVOFLURANE AND DESFLURANE FOR POST-OPERATIVE NEUROCOGNITIVE DYSFUNCTION IN PATIENTS UNDERGOING SPINE SURGERIES : A PROSPECTIVE RANDOMIZED CONTROLLED CLOSE ENDED DOUBLE-BLINDED CLINICAL TRIAL
This study aims to compare the effects of sevoflurane and desflurane on post-operative cognitive dysfunction POCD in young adults undergoing spine surgery. POCD is a temporary cognitive decline following surgery, characterized by impairments in memory, attention, and executive function. It is believed to be caused by mechanisms such as neuroinflammation, oxidative stress, and neurotoxicity, which are often exacerbated by anesthetic agents. Desflurane and sevoflurane are modern anesthetics, with desflurane offering quicker recovery times but having a pungent odor, while sevoflurane provides smoother induction. The study will assess POCD pre-operatively, 24 hours, and 6 months post-surgery using psychometric tests. Secondary objectives include monitoring changes in cognitive scores MoCA and regional cerebral oxygen saturation rSO2 during surgery, and comparing intraoperative hemodynamics. The literature review highlights that POCD can last from months to years, with near-infrared spectroscopy NIRS being used to monitor rSO2 and potentially reduce POCD risk. Hypothesis 1. Desflurane (shorter acting) would be associated with less POCD when compared with sevoflurane 2. Similar rSO2 patterns in both groups 3. Positive correlation between decrease in rSO2 and POCD Incidence The study is a randomized controlled trial with young and middle-aged adults 18-59 years undergoing elective lumbar or thoracic spine surgeries. The sample size is estimated at 140 participants, with inclusion criteria ensuring a relatively healthy population without pre-existing cognitive impairments. The hypothesis is that desflurane, due to its shorter acting profile, will result in less POCD compared to sevoflurane. Ethical considerations include informed consent, confidentiality, and voluntary participation. The expected outcome is that desflurane may favorably impact cognitive function post-surgery due to quicker emergence, reduced exposure time, and improved hemodynamic stability. However, the influence of patient-specific factors and anesthesia management techniques will also play a role in the results.
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