An interventional study of standard care protcol and enhanced recovery protocol in Nausea and Vomiting, Postoperative, sponsored by Minia University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Minia University · Not applicable, Interventional, and Prevention
The use of bariatric surgery in the treatment of severe obesity has several benefits in terms of sustainable weight loss, improvements, or resolution of several metabolic comorbidities as well as improved life expectancy.
Gastric surgery, history of acid reflux and reduction in gastric size, in particular after laparoscopic sleeve gastrectomy (LSG), surgery may further contribute to postoperative nausea and vomiting (PONV).
The combination of antiemetic drugs that act at different receptors is more effective than using only one drug in preventing PONV in patients with increased risk for these events.
After obtaining Institutional Ethical Committee approval and written informed consent from the patients in each case, the ASA score, Simplified Apfel scores14 a measure of PONV risk, and duration of preoperative fasting are calculated for each patient. Patients will be randomly allocated into two groups.
Group 1 (non-ERAS): All patients will receive haloperidol 2 mg, dexamethasone 8 mg, and ondansetron 8 mg in addition to standard care protocol.
Group 2 (ERAS): All patients will receive haloperidol 2 mg, dexamethasone 8 mg, and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.
All patients will receive general anesthesia. The doses of anesthetic drugs for induction and maintenance of anesthesia are calculated with reference to the ideal body weight (IBW) and the corrected body weight (CBW) in patients, where IBW=height (in cm)-100 for men and height (in cm)-105 for women and CBW=IBW+ [0.4 × (current weight-ideal weight)]12.
Anesthesia and Operative Technique for Non-ERAS:
Anesthesia:
Induction of anesthesia IS carried out with propofol 2 mg kg -1 iv of CBW, fentanyl 3 μg kg-1 CBW, and cisatracurium 0.1 mg kg-1 iv of IBW for tracheal intubation. The maintenance IS performed with fentanyl 0.1 to 0.3 μg kg-1 min -1 iv of IBW, isoflurane 1 % mixture of oxygen and air 1:1, and an additional dose of cisatracurium if necessary. Neuromuscular blockade IS reversed with neostigmine up to 0.04 mg kg-1 IV of IBW and atropine up to 0.015 mg kg-1 iv of IBW.
Antiemetic protocol:
Anesthesia and Operative Technique for ERAS:
The institutional ERAS is described in Table 1. Table 1: Technique for ERAS15,16. Preoperative protocols
Pain management • Acetaminophen 1000mg PO 2h before anesthesia
Intraoperative protocols
Anesthesia General anesthesia: TIVA16,17
Antiemetic protocol: • Haloperidol 2mg IS administered immediately after induction of anesthesia and ondansetron IS infused 20 to 30 min prior to the end of the operation.
Pain management • Lidocaine 1 mg kg, then by 1 mg kg-1 hr-1. continuous infusion 1 mg. kg -1h-1. for maintenance.
Abdominal drainage and nasogastric decompression • Nasogastric tubes and abdominal drains should not be used Postoperative protocols Pain management • Bilateral Transversus Abdominis plane block (TAP) at the end of the operation.
PONV treatment • Ondansetron 8 mg IS used as the primary rescue antiemetic and metoclopramide 10 mg IV IS utilized in PONV refractory to ondansetron.
Thromboprophylaxis
Fluid management • Stop IV fluids on POD 1 Early postoperative nutritional care • Stop IV fluids on POD 1
Postoperative Care for both groups:
Rescue Antiemetic The PONV IS defined as at least one episode of nau¬sea, vomiting, or retching. PONV IS evaluated as follows: I = no nausea or vomiting, II = nausea but no vomiting, III = mild to moderate vomiting, and IV = severe and frequent vomiting more than five times within 24h.
The severity of postoperative nausea (PON) IS assessed using a numeric rating scale (I = mild, II = mod¬erate, III = severe).
The severity of postoperative vomiting (POV) IS recorded according to the number of vomiting episodes (I = no vomiting, II = vomiting episodes occurring 1-2 times within 24 h, III = vomiting episodes occurring 3-5 times within 24 h, IV = vomiting episodes occurring more than 5 times within 24 h). The volume of postoperative water intake IS measured during the two periods (0-24 h and 24-36h). Nausea IS assessed hourly during the first two hours, every two hours for the following four hours, and every four hours until the 24th hour. Nausea IS evaluated on a three-point scale from 0 (no nausea), 1 (mild nausea) to 2 (severe nausea). A patient IS classified to have had PONV if any nausea and/or vomiting occurred within the first 24 postoperative hours.
The patient IS given ondansetron IV as the primary rescue antiemetic and metoclopramide 10 mg IV IS utilized in PONV refractory to ondansetron, when there IS an episode of vomiting or if there IS a request at any time made by the patient for treatment of symptoms.
629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.
This study's planned enrollment of 60 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Minia University is the lead sponsor of 368 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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* Age: 18-60 years
Exclusion Criteria:
All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol.
Other: standard care protcol
All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg, and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.
Other: enhanced recovery protocol
All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol.
Also known as: control
All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.
Also known as: ERAC
The incidence of postoperative nausea and vomiting
number and percentage of episode of nausea and vomiting : I = no nausea or vomiting, II = nausea but no vomiting, III = mild to moderate vomiting, and IV = severe and frequent vomiting more than five times within 24h. The severity of postoperative nausea (PON) was assessed using a numeric rating scale (I = mild, II = mod¬erate, III = severe).
Time frame: 36 hours
Time to first administration of rescue antiemetic drug.
Time in minute
Time frame: 36 hours
postoperative opioid consumption.
amount in ml of opioid given in the 36 hours after surgery
Time frame: 36 hours
Time to tolerate oral fluid
time in minute
Time frame: 36 hours
The quality of recovery.
questionnaire: QoR 15 patient survey
Time frame: 36 hours
complications.
number and percentage of complication related to technique of TAP as hematoma formation at the injection site, vascular or lymphatic injury, neurologic symptoms and local anesthetic toxicity
Time frame: 36 hours
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Dec 2023, 4 months after the start.
Of 168 non-industry interventional studies with no phase under Postoperative Nausea and Vomiting, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 4 months is below that.
Counting every sponsor, half of 168 studies reached it within 12 months; a quarter within 5 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Postoperative Nausea and Vomiting →