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

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654649
• Other study ID #: post-spinal paralytic ileus
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2022
• Est. completion date: March 2024

Study information

• Verified date: June 2023
• Source: Assiut University
• Contact: Ghada Abo Elfadl, MD
• Phone: 01005802086
• Email: ghadafadl77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ileus
• Intestinal Pseudo-Obstruction
• Postoperative Ileus

Intervention

Drug:
• 0.9%sodium chloride
Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia
• Dexamethasone
Patients received IV dexamethasone 8 mg in 5ml normal saline 0,9%, just before spinal anesthesia.

Locations

Country	Name	City	State
Egypt	woman health hospital , Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,	24 hours postoperative