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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05654649
Collaborator
(none)
90
1
2
15
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Dexamethasone in the Prevention of Post-spinal Paralytic Ileus After Cesarean Section, Does it Make a Difference: A Randomized Controlled Study
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Group C

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

Drug: 0.9%sodium chloride
Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia

Active Comparator: Group D

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

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

Outcome Measures

Primary Outcome Measures

  1. 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,

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 woman health hospital , Assiut university Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ghada Mohammed AboelFadl, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05654649
Other Study ID Numbers:
  • post-spinal paralytic ileus
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2022