Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 40Years
FEMALE
ID05654649

Dexamethasone in the Prevention of Post-spinal Paralytic Ileus After Cesarean Section, Does it Make a Difference: A Randomized Controlled Study

Led by Assiut University · Updated on 2024-12-02

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Postoperative ileus is a common and challenging condition that occurs after surgery requiring general anesthesia, including cesarean sections. It involves a slowdown or stoppage of normal intestinal movement, leading to symptoms like abdominal pain, distention, nausea, vomiting, delayed gas and stool passage, and difficulty eating. This condition can increase the risk of complications, prolong hospital stays, and add to healthcare costs. Researchers are exploring ways to improve recovery of gastrointestinal function after surgery, focusing on factors like nervous system regulation, inflammation, hormones, and opioid use. Minimally invasive laparoscopic techniques help reduce surgical trauma and may influence recovery. This study compares the effects of two treatments given just before spinal anesthesia in women undergoing cesarean section. One group receives an intravenous dose of 8 mg dexamethasone diluted in saline, while the other group receives a placebo of 5 ml normal saline. Both treatments are administered immediately before spinal anesthesia. The study uses a randomized, triple-blind design to evaluate if dexamethasone can help prevent postoperative ileus. Participants are women aged 18 to 40 years with full-term single pregnancies scheduled for cesarean sections under spinal anesthesia. The main outcome measured is the time to first passage of gas or stool within 24 hours after surgery. Other aspects include monitoring for symptoms of ileus and recovery progress. The study follows participants through the early postoperative period to assess gastrointestinal function and the safety of the treatments being tested.

CONDITIONS

Brief Title

Dexamethasone in the Prevention of Post-spinal Paralytic Ileus After Cesarean Section

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must sign informed consent before joining the study
  • Women aged 18 to 40 years with full-term single pregnancies (37-41 weeks)
  • Classified as American Society of Anaesthesiologists (ASA) class I or II
  • Scheduled for elective or semi-elective cesarean section (category 3 or 4)
  • Undergoing spinal anesthesia for a single baby pregnancy over 32 weeks
Not Eligible

You will not qualify if you...

  • Height less than 150 cm or greater than 180 cm
  • Body mass index (BMI) over 35 kg/m2
  • Contraindication or refusal to have regional anesthesia
  • Presence of cardiovascular diseases including arrhythmias or severe heart valve disease
  • Kidney or liver disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive either IV dexamethasone or placebo just before spinal anesthesia during cesarean section.

1 visit (in-person)

Post-operative Follow-up

Duration - 24 hours postoperative

Participants are observed for recovery of gastrointestinal function after surgery.

1 follow-up visit within 24 hours

Trial Site Locations

Total: 1 location

1

woman health hospital , Assiut university

Asyut, Egypt, 71515

Actively Recruiting

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Research Team

G

Ghada Abo Elfadl, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Postoperative Ileus Complicated with Incomplete Evisceration after Hysterectomy for Benign Pathology.

Aida Petca, Andreea Borislavschi, Mihai Cristian Dumitrascu...

https://pubmed.ncbi.nlm.nih.gov/32155406