A Phase 2 interventional study of Dexamethasone and 10 ml/kg Ringer's lactate in Nausea and Vomiting, Postoperative, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-04-01.
Sponsored by Assiut University · Phase 2, Interventional, and Prevention
Postoperative nausea and vomiting (PONV) are the most common and distressing side effects following Laparoscopic cholecystectomy
In the operating room, standard monitors included electrocardiogram, noninvasive arterial blood pressure, arterial oxygen saturation, and end-tidal carbon dioxide were connected. All patients received standardized anesthetic technique. At the end of surgery, gastric contents were suctioned via an orogastric tube before extubation. Atropine and neostigmine (1/2.5 mg) was given slowly I.V. to antagonize the residual neuromuscular block. Then, the trachea was extubated. Then, patients were transferred to the post-anesthesia care unit in a stable condition. Patients were allowed to drink liquids as soon as requested.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 100 is below the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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American Society of Anesthesiologists (ASA) physical status I or II aged Elective laparoscopic cholecystectomy
Exclusion Criteria:
Steroids use within the last 3 days before surgery Antiemetic use within the last 3 days before surgery Opioids use within the last 3 days before surgery. Patients with liver, cardiac or renal diseases Patients with Pregnancy Patients with Bmi ˃ 30kg/m2 Patients with Delayed wound healing Open surgery
I.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution.
Drug: Dexamethasone · Drug: 10 ml/kg Ringer's lactate
I.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution
Drug: Dexamethasone · Drug: 30 ml/kg Ringer's lactate
5 mg I.V. Dexamethasone just before induction
Also known as: Decadron
Intra-operative 10 ml/kg Ringer's lactate solution .
Also known as: Normal hydration
Intra-operative 30 ml/kg Ringer's lactate solution .
Also known as: super-hydration
Postoperative Nausea and Vomiting (PONV)
A nurse, who was unaware about the groups to which the patient belonged, evaluated patients at 0, 6, and 24 h after surgery for any symptoms of nausea, retching, or vomiting. PONV is classified as early, if occurring up to 6h after surgery, or late, if occurring between 6 h up to 24 postoperatively. A Verbal Descriptive Scale (VDS), was used to assess the severity of PONV: no PONV (grade 0), mild PONV (grade 1), moderate PONV (grade 2) and severe PONV (grade 3)
Time frame: Within the first 24 hours postoperatively
Total number of patients who had nausea, vomiting or retching
Total number of patients who had nausea, vomiting or retching (number)
Time frame: Within the first 24 hours postoperatively
Antiemetic usage
Total amount of ondansetron consumption (mg)
Time frame: Within the first 24 hours postoperatively
Pain Score
A visual analogue scale (appropriate score)
Time frame: Within the first 24 hours postoperatively
Total analgesic consumption
I.V Pethidine (mg)
Time frame: Within the first 24 hours postoperatively
Incidence of wound infection
Number of patients
Time frame: Within the first week postoperatively
Incidence of delayed wound healing
Number of patients
Time frame: Within the first week postoperatively
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Assiut University