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

Phase 1

Recruiting

• Conditions: Postoperative Ileus
• Interventions: Drug: 0.9%sodium chloride; Drug: Dexamethasone

• Registration Number: NCT05654649
• Lead Sponsor: Assiut University

Brief Summary

Postoperative ileus is a perplexing problem for clinical surgeons. It occurs not only after abdominal surgery but also after any surgery that requires general anesthesia. Postoperative ileus is defined as the dysfunction of gastrointestinal motility after surgery, characterized by a decrease in, or stagnation of, intestinal peristalsis.

Detailed Description

Common clinical manifestations include abdominal pain, abdominal distention, nausea, vomiting, delayed flatus, delayed defecation, and inability to consume orally. Postoperative ileus is an uncomfortable experience, enhances the possibility of postoperative complications, prolongs hospital stay, and increases the economic burden. Postoperative gastrointestinal function recovery is of great concern. There is currently an urgent need to improve postoperative recovery of gastrointestinal function. The mechanism of Postoperative ileus varies, including autonomic regulation, inflammatory response, gastrointestinal hormones, and postoperative use of opioid drugs. Surgical gut damage destroys the intestinal barrier, stimulates the sympathetic and parasympathetic nervous systems, and enhances the release of inflammatory factors. These factors precipitate the occurrence of Postoperative ileus. The current use of laparoscopic techniques can reduce incision size and surgical trauma, enabling careful manipulation.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Primary Completion: 2024-12
• Study Completion: 2024-12
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• •All participants will sign an informed consent prior to inclusion in the study.

  • All patients 18-40 years of full-term singleton pregnancy (37-41 weeks).,
  • American Society of Anaesthesiologists (ASA) classification class I and II scheduled.
  • for elective or semi-elective surgery (category 3 and 4 Caesarean sections).
  • All patients under spinal anesthesia for a Single baby pregnancy of more than 32 weeks will be included in this study.

Exclusion Criteria

• will be patients' height < 150 or > 180 cm.
• Body mass index (BMI) >35 kg m-2.
• Contraindication or refusal to undergo regional anesthesia.
• any cardiovascular disease including arrhythmias and severe stenotic valvular heart disease.any renal or hepatic diseased patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	0.9%sodium chloride	Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia
Group D	Dexamethasone	Patients received IV dexamethasone 8 mg in 5ml normal saline 0,9%, just before spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
the time to first passage of flatus and or stool	24 hours postoperative	the time to first passage of flatus and or stool through the first 24 hours and the time of return of intestinal sounds,

Trial Locations

Locations (1)

woman health hospital , Assiut university; 🇪🇬 Assiut, Egypt