Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002423425 Date of Approval: 12/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Shivering after spinal anesthesia
Official scientific title Effects of oral premedication with tramadol, pregabalin or clonidine on post spinal anesthesia shivering in patients undergoing hysteroscopic procedures
Brief summary describing the background and objectives of the trial As for shivering, perioperative hypothermia is the primary cause, which occurs due to neuraxial anaesthesia¿induced inhibition of thermoregulatory mechanism. Shivering occurs as a thermoregulatory response to hypothermia or muscle activity with tonic or clonic patterns, and various frequencies have been noticed. However, in the postoperative period, muscle activity may be increased even with normothermia, suggesting that mechanisms other than heat loss with subsequent decrease in the core temperature contribute to the origin of shivering. These may be uninhibited spinal reflexes, sympathetic over-activity, postoperative pain, adrenal suppression, pyrogen release and respiratory alkalosis. this study aims at assessing the effects of tramadol, pregabalin or clonidine when given as oral premedication before hysteroscopic procedures done under spinal anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Nervous System Diseases,shivering after spinal anesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/08/2017
Actual trial start date 05/09/2017
Anticipated date of last follow up 01/06/2018
Actual Last follow-up date 15/06/2018
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oral premedication with tramadol 100 mg capsule once orally with small sips of water 90 minutes before administering spinal anesthesia 30
Experimental Group oral premedication with pregabalin 150 mg once orally with small sips of water 90 minutes before administering spinal anesthesia 30
Experimental Group oral premedication with clonidine 200 microgram once orally with small sips of water 90 minutes before administering spinal anesthesia 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I and II scheduled for elective hysteroscopy ( estimated by the surgeon to be about 1 hour in duration )under intrathecal anesthesia pre-existing cardiac disease, endocrine disease, chest disease, psychitaric disease, hypertension and/or severe renal or hepatic dysfunction. Current fever or hypothermia. known hypersensitivity to or chronic use of clonidine, pregabalin or tramadol known history of alcohol or substance abuse 25 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/06/2017 faculty of medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome onset of shivering :the time at which shivering starts after spinal anaesthesia once
Secondary Outcome intraoperative compications : nausea and vomiting hypotension/hypertension, tachycardia, bradycardia and/or desaturation. every 5 minutres all through the intraoperative phase
Secondary Outcome Ramsay sedation score assessment: sedation status 60 minutes after administering the premedication just before administering the spinal anesthetic intraoperatively every 15 minutes postoperatively every 30 minutes till completing 6 hours after shift to the ward every 1 hour till completing 24 hours after adminitering the premedication
Secondary Outcome time for first postoperative anagesia requirement time for analgesia requirement after establishing the spinal anesthetic
Primary Outcome the severity of the shivering, the number of attacks of shivering, the time to disappearance of shivering (in minutes) after administering meperidine and the totally received meperidine in mg, incidence of shivering recurrence once
Secondary Outcome postoperative complications ( hypo or hypertension, tachy or bradycardia, postoperative nausea and vomiting, dizziness, During the whole postoperative period till sompketibg 24 hours after taking the premedication
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
khaled gaballah 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled gaballah khgaballah@gmail.com 00201016009073 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Public Enquiries sabry abdallah sabryabdallah222@yahoo.com 00201012378888 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Scientific Enquiries sabry abdallah sabryabdallah222@yahoo.com 01012378888 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
REPORTING
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