Clinical trial NCT05654649: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Postoperative Ileus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: the time to first passage of flatus and or stool
timeFrame: 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: woman health hospital , Assiut university
Study officials:
References:
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.
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.
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.
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.