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

NCT03165123 | Unknown Phase 4

• 1 other identifier: ABCD
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-operative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Direct questionnaire of the patients about their nausea and/or vomiting

  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

  The first 24 hours after surgery

Study Arms (2)

placebo group

PLACEBO COMPARATOR

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

Azithromycin group

ACTIVE COMPARATOR

The patients will receive 250 mg oral Azithromycin 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 Azithromycin tablet; Drug: Intravenous dexamethasone

Interventions

Oral Azithromycin tablet DRUG

Oral azithromycin tablet will be given one hour before induction of anaesthesia.

Azithromycin group

Intravenous dexamethasone DRUG

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

Azithromycin group; placebo group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Abdel-Aleem M, Osman A, Morsy K. Effect of coadministration of dexamethasone with intrathecal morphine on postoperative outcomes after cesarean delivery. Int J Gynaecol Obstet. 2012 Feb;116(2):158-61. doi: 10.1016/j.ijgo.2011.10.002. Epub 2011 Oct 26.

  PMID: 22036059 BACKGROUND

• Rea E, Husbands E. Erythromycin: prophylaxis against recurrent small bowel obstruction. BMJ Support Palliat Care. 2017 Sep;7(3):261-263. doi: 10.1136/bmjspcare-2017-001343. Epub 2017 Mar 29.

  PMID: 28356304 RESULT

• Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.

  PMID: 34002866 DERIVED

MeSH Terms

Conditions

Vomiting

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Central Study Contacts

Fatma Askar, MD

CONTACT

00201005803969; s.askar@aun.edu.eg

Khalid Morsy, MD

CONTACT

00201005677075; khaledmorsy@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 24, 2017
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share