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Preemptive Versus Preventive Antiemetic Treatment

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ClinicalTrials.gov Identifier: NCT03023306
Recruitment Status : Not yet recruiting
First Posted : January 18, 2017
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens

Brief Summary:

Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study.

Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before the start of surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively, 30 min before the end of surgery.

In the operating room standard monitoring and a standardized anesthetic technique will be implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical rating scale) will be recorded at the same time points. Also, when patients received fluids and solid food by mouth will be recorded.


Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Other: Antiemetics perioperatively Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Preemptive Versus Preventive Antiemetic Treatment in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized Double Blind Trial.
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: preemptive group

The preemptive group will receive the anti-emetic regimen i.v. (4 mg of ondansetron) 1h before the start of surgery. During surgery, 30 min before the end of operation, this group will receive i.v. 0.9% NaCl in equal volumes.The intervention consists of the different time points of antiemetic treatment, thus 1h before surgery vs intraopertively.

Intervention: Antiemetic treatment 1h before surgery

Other: Antiemetics perioperatively
Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively

intraoperative group

The preventive group will receive i.v. 0.9% NaCl 1h before surgery and ondansetron 4 mg 30 min before the end of surgery at equal volumes.

Intervention: Antiemetic treatment intraoperatively

Other: Antiemetics perioperatively
Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively




Primary Outcome Measures :
  1. PONV (postoperative nausea vomiting combined) [ Time Frame: 24 hours ]
    Incidence of combined nausea and vomiting postoperatively


Secondary Outcome Measures :
  1. postoperative nausea frequency and intensity [ Time Frame: 24 hours ]
    numerical rating scale of nausea intensity (0-10)

  2. postoperative vomiting frequency [ Time Frame: 24 hours ]
    number of vomits

  3. postoperative pain [ Time Frame: 24 hours ]
    numerical rating scale of pain intensity (0-10)

  4. retching [ Time Frame: 24 hours ]
    if retching exists

  5. PONV (postoperative nausea vomiting combined) [ Time Frame: 24 hours ]
    frequency and intensity of nausea and vomiting



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-III patients
  • Surgical procedure: scheduled for laparoscopic cholecystectomy
  • Type of anesthesia: general

Exclusion Criteria:

  • Antihistamines the last three days
  • Antiemetic drugs the last three days
  • Hiatus hernia
  • reflux
  • Gastrointestinal disease
  • Pregnancy
  • BMI > 35
  • parkinson
  • known allergy to the drugs of the protocol
  • epilepsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023306


Contacts
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Contact: Argyro Fassoulaki, MD PhD DEAA 306936701333 afassou1@otenet.gr
Contact: Chryssoula Staikou, MD, PhD, DESA 00306932352742 c_staikou@yahoo.gr

Locations
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Greece
Aretaieio University Hospital Not yet recruiting
Athens, Attika, Greece, 11528
Contact: Argyro Fassoulaki, MD PhD DEAA    306936701333    fassoula@aretaieio.uoa.gr   
Contact: Chryssoula Staikou, MD PhD DESA    00306932352742    c_staikou@yahoo.gr   
Sponsors and Collaborators
University of Athens

Publications:

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Responsible Party: Argyro Fassoulaki, Professor Emeritus, University of Athens
ClinicalTrials.gov Identifier: NCT03023306     History of Changes
Other Study ID Numbers: IRB No 65/19-06-18
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents