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History of Changes for Study: NCT03023306
Preemptive Versus Preventive Antiemetics
Latest version (submitted October 31, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 13, 2017 None (earliest Version on record)
2 January 24, 2017 Study Status and Eligibility
3 February 21, 2017 Recruitment Status, Study Status, Arms and Interventions, Contacts/Locations, Oversight, Study Identification and IPDSharing
4 October 31, 2018 Recruitment Status, Contacts/Locations, Study Status, Arms and Interventions, Outcome Measures, Study Identification, Eligibility and Study Description
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Study NCT03023306
Submitted Date:  February 21, 2017 (v3)

Open or close this module Study Identification
Unique Protocol ID: IRB No 11139, Date 01-31-2017
Brief Title: Preemptive Versus Preventive Antiemetics
Official Title: Effectiveness of Preemptive Versus Preventive Antiemetic Treatment in Patients Undergoing Thyroidectomy. A Randomized Double Blind Trial.
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2017
Overall Status: Recruiting
Study Start: February 17, 2017
Primary Completion: December 16, 2018 [Anticipated]
Study Completion: December 16, 2018 [Anticipated]
First Submitted: January 13, 2017
First Submitted that
Met QC Criteria:
January 13, 2017
First Posted: January 18, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 21, 2017
Last Update Posted: February 23, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Athens
Responsible Party: Principal Investigator
Investigator: Argyro Fassoulaki
Official Title: Professor Emeritus
Affiliation: University of Athens
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary:

Female patients aged between 20 and 70 years, ASA physical status I-II, and scheduled for thyroidectomy under general anaesthesia will be enrolled in the study.

Patients will be randomized to the preemptive group to receive an antiemetic regime the day before surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively.

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 immediately after extubation and six hourly thereafter for the first 24 hours. Pain scores assessed by VAS (verbal analogue scale) will be recorded at the same time points. Also, if patients received fluids and solid food by mouth.

Detailed Description:
Open or close this module Conditions
Conditions: Postoperative Nausea and Vomiting
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 115 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: preemptive group

The preemptive group will receive the anti-emetic regimen i.v. (10 mg of metoclopramide at 18 pm and 22 pm, and100 mg of dimenhydrinate at 22 pm) the day before surgery. During surgery this group will receive i.v. 0.9% NaCl in volumes equal to the volume of 10 mg of metoclopramide before anesthesia induction and 30 min after skin incision. Thirty minutes after skin incision 0.9% NaCl equal in volume with the volume of 100 mg dimenhydrinate will be given as well.

The intervention consists of the different time points of antiemetic treatment, thus the day before surgery.

Intervention: Antiemetic treatment the day before surgery

Antiemetic treatment the day before surgery vs intraoperatively
Preemptive group The antiemetic regime thus 2 doses of 10 mg each metoclopramide will be administered the day before surgery Intraoperative group The antiemetic regime thus 2 doses of 10 mg each metoclopramide will be administered intraoperatively
Active Comparator: intraoperative group

The day before surgery the intraoperative group will receive i.v. 0.9% NaCl at 18 pm and 22 pm in volumes equal to the volume of 10 mg of metoclopramide; also 0.9% NaCl in volume equal to the volume of 100 mg dimenhydrinate at 22 pm will be given. During surgery the active comparator group will receive i.v. 10 mg of metoclopramide and 100 mg of dimenhydrinate instead of NaCl at the same time points as the preemptive group.

Intervention: Antiemetic treatment intraoperatively

Antiemetic treatment the day before surgery vs intraoperatively
Preemptive group The antiemetic regime thus 2 doses of 10 mg each metoclopramide will be administered the day before surgery Intraoperative group The antiemetic regime thus 2 doses of 10 mg each metoclopramide will be administered intraoperatively
Open or close this module Outcome Measures
Primary Outcome Measures:
1. PONV (postoperative nausea vomiting)

[Time Frame: 24 hours]
Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 70 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • ASA physical status I-II patients
  • Surgical procedure: scheduled for thyroidectomy
  • Type of anesthesia: general

Exclusion Criteria:

  • Antihistamines the last three days
  • Antiemetic drugs the last three days
  • Hiatus hernia
  • Gastrointestinal disease
  • Pregnancy
  • BMI > 35
Open or close this module Contacts/Locations
Central Contact Person: Argyro Fassoulaki, MD PhD DEAA
Telephone: 306936701333
Email: afassou1@otenet.gr
Central Contact Backup: Aimilia Vassi, MD PhD
Telephone: 306938691476
Email: applevass@yahoo.gr
Locations: Greece, Attika
St Savvas Hospital
[Recruiting]
Athens, Attika, Greece, 11522
Contact:Contact: Argyro Fassoulaki, MD PhD DEAA 306936701333 fassoula@aretaieio.uoa.gr
Contact:Contact: Aimilia Vassi, MD PhD 306938691476 applevass@yahoo.gr
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: Odom-Forren J, Rayens MK, Gokun Y, Jalota L, Radke O, Hooper V, Wiggins AT, Apfel CC. The Relationship of Pain and Nausea in Postoperative Patients for 1 Week After Ambulatory Surgery. Clin J Pain. 2015 Oct;31(10):845-51. doi: 10.1097/AJP.0000000000000170. PubMed 25370136
Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramèr MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum in: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494. PubMed 24356162
Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3. PubMed 23035051
Apfel CC, Meyer A, Orhan-Sungur M, Jalota L, Whelan RP, Jukar-Rao S. Supplemental intravenous crystalloids for the prevention of postoperative nausea and vomiting: quantitative review. Br J Anaesth. 2012 Jun;108(6):893-902. doi: 10.1093/bja/aes138. Review. PubMed 22593126
Walldén J, Flodin J, Hultin M. Validation of a prediction model for post-discharge nausea and vomiting after general anaesthesia in a cohort of Swedish ambulatory surgery patients. Eur J Anaesthesiol. 2016 Oct;33(10):743-9. doi: 10.1097/EJA.0000000000000473. PubMed 27270883
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