Dexamethasone in Prolonging the Duration of Spinal Anesthesia Among Pregnant Patients

NCT ID: NCT07088146

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-20

Study Completion Date

2025-10-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Anesthesia Post Operative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group Dexamethasone

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Immediately after sub-arachnoid block 8mg of Dexamethasone will be administered intravenously

Group Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2ml of Normal saline will be given intravenously immediately after administration of spinal anesthesia

Interventions

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Dexamethasone

Immediately after sub-arachnoid block 8mg of Dexamethasone will be administered intravenously

Intervention Type DRUG

Placebo

2ml of Normal saline will be given intravenously immediately after administration of spinal anesthesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rawalpindi Medical College

OTHER

Sponsor Role lead

Responsible Party

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Huda Tariq

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abeera Zareen, MBBS,FCPS

Role: STUDY_CHAIR

Rawalpindi Medical College

Locations

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Benazir Bhutto Hospital Rawalpindi

Rawalpindi, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Huda Tariq, MBBS

Role: CONTACT

+92-321-8829413

Facility Contacts

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Huda Tariq, MBBS

Role: primary

+92-321-8829143

Abeera Zareen, MBBS, FCPS

Role: backup

+92-332-8559637

References

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Abdel-Wahab AH, Abd Alla ES, Abd El-Azeem T. Effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in lower abdominal surgery, Randomized controlled trial. BMC Anesthesiol. 2023 Sep 22;23(1):323. doi: 10.1186/s12871-023-02282-y.

Reference Type BACKGROUND
PMID: 37736711 (View on PubMed)

Related Links

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Other Identifiers

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201/IREF/RMU/2025

Identifier Type: -

Identifier Source: org_study_id

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