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Recruiting NCT07088146

Dexamethasone in Prolonging the Duration of Spinal Anesthesia Among Pregnant Patients

Phase IV Interventional Spinal Anesthesia Post Operative Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexamethasone, Placebo.
Who it may be relevant to
Registry conditions: Spinal Anesthesia, Post Operative Analgesia. Basic parameters: 16 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Role of Intravenous Dexamethasone in Prolonging the Duration of Sub-Arachnoid Block in Pregnant Patients Undergoing Lower Segment Cesarean Section

Overview

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

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.

Interventions

  • Drug Dexamethasone
    Immediately after sub-arachnoid block 8mg of Dexamethasone will be administered intravenously
  • Drug Placebo
    2ml of Normal saline will be given intravenously immediately after administration of spinal anesthesia

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Pakistan · 1 center
  • Benazir Bhutto Hospital Rawalpindi — Rawalpindi

Publications

  • 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. PMID 37736711

Identifiers

NCT: NCT07088146 · 201/IREF/RMU/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗