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NCT Number: NCT05654649

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

woman health hospital , Assiut university

Asyut, 71515, Egypt

Location status: Recruiting

Location contact

Ghada M Aboelfadl, MD

CONTACT

[email protected]

01005802086

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.9%sodium chloride

Drug

Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia

Dexamethasone

Drug

Patients received IV dexamethasone 8 mg in 5ml normal saline 0,9%, just before spinal anesthesia.

Primary outcomes

  1. the time to first passage of flatus and or stool

    Time frame: 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,

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada Abo Elfadl, MD

CONTACT

[email protected]

01005802086

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2022
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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