ClinicalTrials.gg
Status unknownNCT05996887Updated Aug 21, 2023

Impact of ERAS on Postoperative Nausea and Vomiting After Sleeve

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 sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  1. 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.

  2. Antiemetic protocol:

    • Dexamethasone 8mg IS administered 90 min prior to induction of anesthesia.
    • Haloperidol 2 mg after induction of anesthesia and ondansetron 8 mg IS infused 20 to 30 min prior to the end of the operation.
  3. Postoperative Analgesia Analgesia IS done with intravenous ketorolac 30 mg immediately after the induction of anesthesia and maintained at 8 h and acetaminophen IV 1 g every 6 h. IS used in the PACU to keep PVRS\<4. Patient-controlled analgesia (PCA) containing 20 mg Nalbuphine (Nalbuphine HCl 20mg / 1ml) to 100 ml with normal saline over 24 hours. The PCA infuser unit IS infused at a rate of 2 ml.h-1 with a lockout time of 15 min \& bolus of 1 ml per time. The intensity of pain IS measured by a pain verbal rating scale (PVRS, 0=no pain to 10=worst pain)12.

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

  • Gabapentin 400 ml PO before anesthesia Diet • Clear liquids until 3 h prior to surgery PONV prevention • H2 receptor antagonist
  • Dexamethasone 8mg IS administered 90 min prior to induction of anesthesia Preoperative fasting
  • Fasting to solids until 6 h before induction and clear liquids until 2 h before induction.

Intraoperative protocols

Anesthesia General anesthesia: TIVA16,17

  • Propofol (2 mg kg-1 iv of CBW). GA IS maintained with i.v. infusion of propofol (75-150 mg kg-1 min-1).
  • Dexmedetomidine (0.5 mg kg-1 i.v. over 10 min) IS initiated and maintained with an i.v. infusion of dexmedetomidine (0.1-0.3 mg kg-1h-1).
  • Ketamine a single dose before incision (0.5 mg kg-1 i.v.) then 0.5 mg.kg-1.h-1.
  • Muscle relaxation with cisatracurium 0.1 mg kg-1 iv of IBW IS maintained with boluses 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.
  • Patients are ventilated with a mixture of oxygen and air. At the end of the surgery, muscle relaxation IS reversed with neostigmine (up to 5 mg) and glycopyrrolate (0.2-0.8 mg).

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.

  • Magnesium Sulfate (30 mg/kg) + continuous infusion (10 mg/kg/h)
  • Bilateral Transversus Abdominis plane block (TAP) at the end of the operation. Fluid management • Goal-directed IV fluid therapy, avoiding both restrictive or liberal strategies.

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.

  • Lidocaine IV drip for 24 h
  • Acetaminophen IV transitioned to PO.
  • Ketoralac 30 mg every 8 h
  • acetaminophen IV 1 g every 6 h.
  • IV Nalbuphine, breakthrough pain. The intensity of pain IS measured by a pain verbal rating scale (PVRS, 0=no pain to 10=worst pain)

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

  • Thromboprophylaxis should involve mechanical and pharmacological measures. Doses and duration of treatment should be individualized.

Fluid management • Stop IV fluids on POD 1 Early postoperative nutritional care • Stop IV fluids on POD 1

  • Clear liquids on POD 0 PO: Per oral, PONV: postoperative nausea and vomiting, IV: intravenous, prn: when required, POD: postoperative day.

Postoperative Care for both groups:

  1. Feeding A liquid diet IS prescribed for the first postoperative day, followed by a diet containing broth without residue as tolerated by the patient.
  2. 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.

  3. Outcome Variables Secondary endpoints included time to first administration of rescue antiemetic drug, the number of rescues, postoperative opioid consumption, time to tolerate oral fluid, and time to readiness for discharge. Data collection IS done by blinded personnel at the end of the following postoperative time intervals: 0-2, 2-12, 12-24, and 24-36 h, postoperatively. The quality of recovery IS assessed by QoR-1518 questionnaires at discharge. In patients who are discharged before 36 h, the questionnaires are filled out during a telephone call the next morning.
02

Conditions studied

  • Nausea and Vomiting, Postoperative

Keywords

  • sleeve gastrectomy
  • nausea
  • vomiting
03

In context

Postoperative Nausea and Vomiting

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

* Age: 18-60 years

  • Sex: Both sex
  • ASA Physical Status: II, III.
  • Body mass index: Between 40 and 60 kg/m2.
  • Participants: Patients who are undergoing elective Sleeve Gastrectomy

Exclusion criteria

Exclusion Criteria:

  • Patients with hypersensitivity or contraindication to haloperidol, dexamethasone, or ondansetron.
  • Serious complications in the perioperative period (such as shock, cardiac arrest, hemorrhage, needing transfusion).
  • Psychiatric disorder.
  • History of migraine.
  • Use of opioid, hormonal, anti-inflammatory, and antiemetic medication 24 h prior to surgery.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    non- enhanced recovery after surgery

    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

  • Active comparator
    enhanced recovery after surgery

    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

Interventions

  • Otherstandard care protcol

    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

  • Otherenhanced recovery protocol

    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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to first administration of rescue antiemetic drug.

    Time in minute

    Time frame: 36 hours

  2. postoperative opioid consumption.

    amount in ml of opioid given in the 36 hours after surgery

    Time frame: 36 hours

  3. Time to tolerate oral fluid

    time in minute

    Time frame: 36 hours

  4. The quality of recovery.

    questionnaire: QoR 15 patient survey

    Time frame: 36 hours

  5. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Jul 29, 2023
First posted
Aug 18, 2023
StartActual
Jul 30, 2023
Primary completionEst.
Dec 1, 2023
CompletionEst.
Jan 1, 2024
Last update
Aug 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05996887
Lead sponsor
Minia University
Responsible party
haidy salah mansour (assistant professor of anesthesia and ICU, Minia University) — Principal investigator
First posted
Aug 18, 2023
Start date
Jul 30, 2023
Primary completion
Dec 1, 2023 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Aug 21, 2023

Study contacts

haidy s mansour, MD
Contact
haidy_mourad@yahoo.com
1221802324 ext. 0020
hassan M hetta, MD
Contact
hassan.hetta@mu.edu.eg
1010901114 ext. 0020
haidy S mansour, MD
principal investigator · Assistant professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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