| CTRI Number |
CTRI/2026/02/102986 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares two anesthesia medicines to see how well a brain monitor shows how deeply a patient is asleep during abdomen surgery |
|
Scientific Title of Study
|
Correlation of Bispectral Index with Depth of Sedation: A Comparison Between Dexmedetomidine and Propofol in Patients Undergoing Abdominal Surgery Under General Anesthesia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saptagiri Mypati |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College & Hospital |
| Address |
Room no 14 department of anaesthesiology
Vinayaka missions kirupananda variyar medical College and hospital , chinnaseeragapadi
Salem
636308
Salem
TAMIL NADU
636308
India |
| Phone |
7842255343 |
| Fax |
|
| Email |
saptagiri.mypati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V A Sabapathy |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College & Hospital |
| Address |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saptagiri Mypati |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College & Hospital |
| Address |
Room no 14 department of anaesthesiology
Vinayaka missions kirupananda variyar medical College and hospital , chinnaseeragapadi
Salem
636308
Salem
TAMIL NADU
636308
India |
| Phone |
7842255343 |
| Fax |
|
| Email |
saptagiri.mypati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
|
|
Primary Sponsor
|
| Name |
Saptagiri Mypati |
| Address |
Room no 14 department of anaesthesiology
Vinayaka missions kirupananda variyar medical College and hospital , chinnaseeragapadi
Salem
636308 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Saptagiri Mypati |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
Room no 14 department of anaesthesiology general anaesthesia
Salem
TAMIL NADU |
7842255343
saptagiri.mypati@gmail.com |
|
|
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: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmeditomidine |
Dexmedetomidine will be administered intravenously. A loading dose of 1 µg/kg will be given over 10 minutes, followed by a continuous intravenous infusion at a rate of 0.5 µg/kg/hour. The infusion will be started after induction of general anesthesia and continued intraoperatively until the end of surgery. The infusion rate may be titrated as required to maintain a target Bispectral Index (BIS) value between 40 and 60.
|
| Comparator Agent |
Propofol |
Propofol will be administered intravenously as a continuous infusion at a rate of 50–150 µg/kg/min, titrated according to patient response to maintain a target BIS value between 40 and 60. The infusion will be started after induction of general anesthesia and continued intraoperatively until completion of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged eighteen to sixty five years of either gender belonging to ASA physical status one or two scheduled for elective abdominal surgery under general anesthesia and willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with neurological disorders affecting electroencephalogram, chronic use of sedatives or opioids, severe cardiac hepatic or renal disease, known allergy to study drugs, pregnant or lactating women and patients unwilling to participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of the study is the correlation between Bispectral Index (BIS) values and clinical depth of sedation assessed using the Ramsay Sedation Scale (RSS) in patients receiving dexmedetomidine or propofol during abdominal surgery under general anesthesia.
This primary outcome is used to assess the effect of the intervention and comparator agents on depth of sedation and forms the basis for comparison between the two groups. |
*Baseline (before induction of anesthesia)
*Post-induction
*At skin incision
*Every 5 minutes intraoperatively
*At the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of bispectral index values between dexmedetomidine and propofol groups. |
Intraoperative period. |
| Hemodynamic parameters including heart rate and blood pressure. |
Baseline, intraoperative period and end of surgery. |
| Recovery profile including time to eye opening extubation and orientation. |
Postoperative period. |
| Incidence of adverse events related to study drugs. |
Intraoperative and postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a prospective randomized comparative clinical study conducted in adult patients undergoing elective abdominal surgery under general anesthesia. The study aims to evaluate the correlation between bispectral index values and depth of sedation using dexmedetomidine and propofol.
A total of sixty patients belonging to ASA physical status one and two will be randomly allocated into two groups. Group D will receive dexmedetomidine infusion and Group P will receive propofol infusion for intraoperative sedation. Standard anesthesia monitoring along with bispectral index monitoring will be used in all patients.
Depth of sedation will be assessed using bispectral index values and Ramsay sedation scale at predefined intraoperative time points. Hemodynamic parameters recovery characteristics and adverse events will also be recorded and compared between the two groups.
The study aims to determine the correlation between bispectral index and clinical depth of sedation and to compare the efficacy and safety of dexmedetomidine and propofol during abdominal surgery under general anesthesia. |