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

Primary Purpose

Postoperative Ileus

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
0.9%sodium chloride
Dexamethasone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Ileus

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • woman health hospital , Assiut universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group C

Group D

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 8, 2022
Last Updated
June 12, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05654649
Brief Title
Dexamethasone in the Prevention of Post-spinal Paralytic Ileus After Cesarean Section
Official Title
Dexamethasone in the Prevention of Post-spinal Paralytic Ileus After Cesarean Section, Does it Make a Difference: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Patients received IV dexamethasone 8 mg in 5ml normal saline 0,9%, just before spinal anesthesia.
Intervention Type
Drug
Intervention Name(s)
0.9%sodium chloride
Intervention Description
Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Patients received IV dexamethasone 8 mg in 5ml normal saline 0,9%, just before spinal anesthesia.
Primary Outcome Measure Information:
Title
the time to first passage of flatus and or stool
Description
the time to first passage of flatus and or stool through the first 24 hours and the time of return of intestinal sounds,
Time Frame
24 hours postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghada Abo Elfadl, MD
Phone
01005802086
Email
ghadafadl77@gmail.com
Facility Information:
Facility Name
woman health hospital , Assiut university
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghada M Aboelfadl, MD
Phone
01005802086
Email
ghadafadl77@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31310924
Citation
Deng WW, Lan M, Peng AF, Chen T, Li ZQ, Liu ZL, Liu JM. The risk factors for postoperative ileus following posterior thoraco-lumbar spinal fusion surgery. Clin Neurol Neurosurg. 2019 Sep;184:105411. doi: 10.1016/j.clineuro.2019.105411. Epub 2019 Jul 1.
Results Reference
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PubMed Identifier
32155406
Citation
Petca A, Borislavschi A, Dumitrascu MC, Sandru F, Geoarsa M, Petca RC. Postoperative Ileus Complicated with Incomplete Evisceration after Hysterectomy for Benign Pathology. Chirurgia (Bucur). 2020 Jan-Feb;115(1):112-119. doi: 10.21614/chirurgia.115.1.112.
Results Reference
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PubMed Identifier
11091234
Citation
Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
Results Reference
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PubMed Identifier
26105552
Citation
Tevis SE, Carchman EH, Foley EF, Harms BA, Heise CP, Kennedy GD. Postoperative Ileus--More than Just Prolonged Length of Stay? J Gastrointest Surg. 2015 Sep;19(9):1684-90. doi: 10.1007/s11605-015-2877-1. Epub 2015 Jun 24.
Results Reference
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Dexamethasone in the Prevention of Post-spinal Paralytic Ileus After Cesarean Section

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