| CTRI Number |
CTRI/2026/01/101328 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational cross-sectional study |
| Study Design |
Other |
|
Public Title of Study
|
Study to find whether carbon dioxide levels during spinal anaesthesia can predict the need for oxygen after surgery in patients receiving spinal anaesthesia with pain relieving opioids. |
|
Scientific Title of Study
|
Correlation Between Intraoperative End Tidal Carbon Dioxide Value And Post Operative Oxygen Requirement In Patients Under Going Spinal Anaesthesia With Opioid As An Additive Drug Observational Cross Sectional Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PMeghana |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
SSSMCRI Womens hostel,
Shri Sathya Sai Medical College And Research Institute,
Ammapettai, Kancheepuram,Tamil Nadu,India.
SSSMCRI Womens hostel,
Shri Sathya Sai Medical College And Research Institute,
Ammapettai, Kancheepuram,Tamil Nadu,India.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
7013123640 |
| Fax |
|
| Email |
meghanapidathala23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Krishna Prasad.T |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Shri Sathya Sai Medical College And Research Institute,
Ammapettai, Kancheepuram,Tamil Nadu,India.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PMeghana |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
SSSMCRI Womens hostel,
Shri Sathya Sai Medical College And Research Institute,
Ammapettai, Kancheepuram,Tamil Nadu,India.
SSSMCRI Womens hostel,
Shri Sathya Sai Medical College And Research Institute,
Ammapettai, Kancheepuram,Tamil Nadu,India.
TAMIL NADU
603108
India |
| Phone |
7013123640 |
| Fax |
|
| Email |
meghanapidathala23@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr P Meghana |
| Address |
SSSMCRI Womens hostel
Shri Sathya Sai Medical College And Research Institute
Ammapettai Kancheepuram Tamil Nadu India. |
| 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 P Meghana |
Shri Sathya Sai Medical College and Research Intstitute |
Department of Anaesthesiology, 2nd floor OT complex, Shri Sathya Sai Medical College and Research Intstitute
Ammapettai, Chengalpet district,Tamil Nadu ,
India
Kancheepuram
TAMIL NADU |
7013123640
meghanapidathala23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Sathya Sai Medical College & Research Institute,Decision of the Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
There is no comparator or control group in this observational study.Outcomes are observed and recorded. |
| Intervention |
Not Applicable |
This is a Non-interventional observational cross-sectional study.No intervention is assigned by the investigator.Spinal anaesthesia with opioid additive is administered as part of routine institutional clinical practice.The study only involves monitoring intra operative end tidal carbon dioxide and postoperative oxygen requirement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status 1 and 2
Patients scheduled for elective lower limb or lower abdominal surgery under spinal anaesthesia with opioid as and additive drug. |
|
| ExclusionCriteria |
| Details |
Patients With Pre Existing respiratory disease.
Patient Requiring General Anaesthesia Or Patient Getting Converted To General Anaesthesia.
Patient With Known Allergy To Local Anaesthetics Or Opioids, Patients With Baseline Oxygen Saturation Less Than 94 Percentage In Room Air. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Prevent Respiratory Depression in Patients Under Going Spinal Anaesthesia With Opioid As An Additive Drug. |
First 24hrs after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
27/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 an observational cross-sectional study designed to evaluate the relationship between intraoperative end-tidal carbon dioxide Value levels and postoperative oxygen requirements in patients undergoing spinal anaesthesia with an opioid additive.
Spinal anaesthesia is commonly used for lower limb and lower abdominal surgeries. Intrathecal opioids enhance analgesia but may cause respiratory depression, leading to postoperative hypoxia. Monitoring intraoperative end-tidal carbon dioxide Value provides an early indicator of ventilatory compromise, while postoperative oxygen requirement serves as a clinical marker of respiratory adequacy.
The study will be conducted in a tertiary care teaching hospital between August 2025 and January 2027, including 60 adult patients (ASA I–II, aged 18–65 years) scheduled for elective lower limb or lower abdominal surgeries under spinal anaesthesia with opioid additive.
Primary Objective: To evaluate the correlation between intraoperative end-tidal carbon dioxide Value levels and postoperative oxygen requirement. Secondary Objectives: To assess the requirement and duration of postoperative oxygen therapy and to analyze the relationship between intraoperative sedation and postoperative respiratory outcomes.
Intraoperative end-tidal carbon dioxide Value will be monitored continuously using a sidestream capnograph, and postoperative oxygen saturation will be assessed for 24 hours in the Post Anaesthesia Care Unit. Supplemental oxygen will be provided if Saturation falls below 92%.
The findings are expected to provide insights into predicting postoperative oxygen needs, enabling early identification of patients at risk of opioid-induced respiratory compromise and guiding safer perioperative management. |