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

NCT ID: NCT05654649

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Postoperative Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group C

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

Group Type PLACEBO_COMPARATOR

0.9%sodium chloride

Intervention Type DRUG

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

Group D

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Interventions

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0.9%sodium chloride

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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woman health hospital , Assiut university

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ghada Abo Elfadl, MD

Role: CONTACT

[email protected]
01005802086

Facility Contacts

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Ghada M Aboelfadl, MD

Role: primary

[email protected]
01005802086

References

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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.

Reference Type BACKGROUND
PMID: 31310924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32155406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11091234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26105552 (View on PubMed)

Other Identifiers

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post-spinal paralytic ileus

Identifier Type: -

Identifier Source: org_study_id