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Effect of Using Erythromycin A Versus Placebo With Dexamethasone in Prevention of Post-spinal Nausea and Vomiting.

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ClinicalTrials.gov Identifier: NCT03165123
Recruitment Status : Not yet recruiting
First Posted : May 24, 2017
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
KAGergis, Assiut University

Brief Summary:
Postoperative nausea and vomiting is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery in inpatients. Postoperative nausea and vomiting is one of the most common causes of patient dissatisfaction after anesthesia, with reported incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. In addition, postoperative nausea and vomiting is regularly rated in preoperative surveys, as the anesthesia outcome the patient would most like to avoid. While suture dehiscence, aspiration of gastric contents, esophageal rupture, and other serious complications associated with postoperative nausea and vomiting are rare, nausea and vomiting is still an unpleasant and all-too-common postoperative morbidity that can delay patient discharge from the post-anesthesia care unit and increase unanticipated hospital admissions in outpatients.

Condition or disease Intervention/treatment Phase
Post-operative Nausea and Vomiting Drug: Oral Erythromycin A tablet Drug: Intravenous dexamethasone Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Adding Erythromycin A to Dexamethasone in Preventing Post-operative Nausea and Vomiting in Caesarean Section Under Spinal Anesthesia With Spinal Opiate.
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
Placebo Comparator: placebo group
The patients will receive oral placebo tablet, one hour before induction of anesthesia and 5 mg Intra-venous dexamethasone within 1-2 minutes after the umbilical cord is clamped.
Drug: Intravenous dexamethasone
5 mg of intravenous dexamethasone is given within one to two minutes after the umbilical cord is clamped.

Active Comparator: Erythromycin A group
The patients will receive 250 mg oral Erythromycin A tablet, one hour before induction of anesthesia and 5 mg Intra-venous dexamethasone within 1-2 minutes after the umbilical cord is clamped.
Drug: Oral Erythromycin A tablet
Oral erythromycin A tablet will be given one hour before induction of anaesthesia.

Drug: Intravenous dexamethasone
5 mg of intravenous dexamethasone is given within one to two minutes after the umbilical cord is clamped.




Primary Outcome Measures :
  1. Direct questionnaire of the patients about their nausea and/or vomiting [ Time Frame: The first 24 hours after surgery ]
    1. Did you experience nausea during the first 24 hours after your surgery?

      1. yes
      2. no [if no, please skip to question 5]
    2. How long did the nausea last? ....... hours.
    3. How would you describe the nausea at its worst?

      1. mild
      2. moderate
      3. severe
      4. intolerable
    4. How many times you felt nauseated? ......
    5. Did you experience vomiting during the first 24 hours after your surgery?

      1. yes
      2. no [ if no, please skip the next part of the questionnaire]
    6. How would you describe the vomiting at its worst?

      1. mild
      2. moderate
      3. severe
      4. intolerable
    7. How many times you vomited during the first 24 hours after your surgery? .......
    8. Estimate the amount of the vomiting?

      1. small amount
      2. moderate amount
      3. large amount



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: 1- women classified according to American Society of anaesthesiologists grade I between the ages 18 to 38 years scheduled for elective Caesarean Section under spinal anesthesia who are normal healthy women, non smokers, no or minimal alcohol use.

2- women classified as American Society of Anaesthesiologists grade Il between the ages 18 to 38 years scheduled for elective Caesarean Section under spinal anesthesia who are women with mild systemic disease without functional limitations as current smokers, social alcohol drinker, pregnant, women with body mass index between 30 and 40, women with well-controlled diabetas, hypertension or mild lung diseases.

Exclusion Criteria:

  1. Women who has obstetric complications.
  2. Women with evidence of foetal compromise.
  3. Patients who have gastro-intestinal diseases.
  4. Patients who administrated anti-emetic medication in the previous 24 hours before operation.

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): NCT03165123


Contacts
Contact: Fatma Askar, MD 00201005803969 s.askar@aun.edu.eg
Contact: Khalid Morsy, MD 00201005677075 khaledmorsy@gmail.com

Sponsors and Collaborators
Assiut University

Publications of Results:
Other Publications:
Responsible Party: KAGergis, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03165123     History of Changes
Other Study ID Numbers: ABCD
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Dexamethasone acetate
Dexamethasone
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action