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Nausea and Vomiting, PostoperativeNCT05996887

Impact of ERAS on Postoperative Nausea and Vomiting After Sleeve

A study testing enhanced recovery protocol in people with Nausea and Vomiting, Postoperative, run by Minia University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Nausea and Vomiting, Postoperative
What is being tested?
enhanced recovery protocol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
30 Jul 2023to 1 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Minia University

    Minya, Minya Governorate, 61511

    haidy s mansour, ass prof, 1221802324 ext. 0020, Hassan.Hetta@mu.edu.eg

    hassan M hetta, lecturer, 1010901114 ext. 0020, hassan.hetta@mu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Impact of Enhanced Recovery After Surgery (ERAS) for Sleeve Gastrectomy on Postoperative Nausea and Vomiting: Controlled Randomized Study.

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.
  1. 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.
Being tested
standard care protcol, enhanced recovery protocol
Keywords
sleeve gastrectomy, nausea, vomiting
Medical subject headings
Postoperative Nausea and Vomiting, Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard care protcolOther

    Also called control

    All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol.

  • enhanced recovery protocolOther

    Also called ERAC

    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.

Study groups in NCT05996887
Study groupRoleWhat they receive
non- enhanced recovery after surgeryPlacebo comparatorAll patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol.
Receives: Other: standard care protcol
enhanced recovery after surgeryActive comparatorAll 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.
Receives: Other: enhanced recovery protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 36 hours

Secondary outcomes (5)
  1. Time to first administration of rescue antiemetic drug.

    Time in minute

    Measured: 36 hours

  2. postoperative opioid consumption.

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

    Measured: 36 hours

  3. Time to tolerate oral fluid

    time in minute

    Measured: 36 hours

  4. The quality of recovery.

    questionnaire: QoR 15 patient survey

    Measured: 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

    Measured: 36 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start30 Jul 2023
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996887
Sponsor's protocol ID
820:6/2023
Status last verified
Aug 2023
First submitted
29 Jul 2023
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing enhanced recovery protocol in people with Nausea and Vomiting, Postoperative, run by Minia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact haidy s mansour, MD (1221802324 ext. 0020, haidy_mourad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of postoperative nausea and vomiting (time frame: 36 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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