- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07088146
- Original Trial
Dexamethasone in Prolonging the Duration of Spinal Anesthesia Among Pregnant Patients
July 19, 2025 updated by: Huda Tariq, Rawalpindi Medical College
Role of Intravenous Dexamethasone in Prolonging the Duration of Sub-Arachnoid Block in Pregnant Patients Undergoing Lower Segment Cesarean Section
Lower segment C section is one of the most commonly performed surgeries worldwide.
It is performed in spinal anesthesia.
During Spinal Anesthesia a local anesthetic drug is administered in a space surrounding spinal cord and it blocks nerves originating from spinal cord providing both anesthesia and analgesia.
This technique avoids harmful exposure of drugs to the baby inside the womb of mother.
However this technique provides anesthesia and analgesia of limited duration which can be prolonged by addition of drugs to patient management regimen.
One such drug is Dexamethasone which is a steroid commonly administered in the peri-operative period.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
To prolong the duration of Sub-Arachnoid block number of drugs which are known as adjuvants can be used.
One of the commonly used adjuvant is Dexamethasone a steroid given by intravenous route having anti-emetic and anti-inflammatory effect.
This drug also prolongs the duration of Sub-Arachnoid block which can be helpful in case of lengthy surgical procedure and also extends the duration of analgesia in the post operative period.
Study Type
Interventional
Enrollment (Estimated)
110
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huda Tariq, MBBS
- Phone Number: +92-321-8829413
- Email: Huda8829@gmail.com
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Recruiting
- Benazir Bhutto Hospital Rawalpindi
-
Contact:
- Huda Tariq, MBBS
- Phone Number: +92-321-8829143
- Email: Huda8829@gmail.com
-
Contact:
- Abeera Zareen, MBBS, FCPS
- Phone Number: +92-332-8559637
- Email: abeerajsk@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) class: II and above.
- Elective Cesarean section under Spinal Anesthesia.
Exclusion Criteria:
- Gestational diabetes
- Body mass index >35 kg/m2
- Diabetes mellitus
- Adrenal insufficiency
- Chronically receiving steroids
- Allergic to study medications
- Sensory block level less than T4
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group Dexamethasone
|
Immediately after sub-arachnoid block 8mg of Dexamethasone will be administered intravenously
|
|
Placebo Comparator: Group Control
|
2ml of Normal saline will be given intravenously immediately after administration of spinal anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time for block to regress by two dermatomes in post operative period
Time Frame: This will be the time in minutes from end of C section in post operative period for the block to regress by two dermatomes
|
This will be the time in minutes from end of C section in post operative period for the block to regress by two dermatomes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to rescue analgesia
Time Frame: This will be the time in minutes from the end of Cesarean section in the post operative period to first rescue analgesia.
|
This will be the time in minutes from the end of Cesarean section in the post operative period to first rescue analgesia.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Abeera Zareen, MBBS,FCPS, Rawalpindi Medical College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2025
Primary Completion (Estimated)
October 20, 2025
Study Completion (Estimated)
October 20, 2025
Study Registration Dates
First Submitted
July 19, 2025
First Submitted That Met QC Criteria
July 19, 2025
First Posted (Actual)
July 28, 2025
Study Record Updates
Last Update Posted (Actual)
July 28, 2025
Last Update Submitted That Met QC Criteria
July 19, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201/IREF/RMU/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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