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.: PACTR201709002556259 Date of Approval: 26/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Agitation and Pain relief in rinoseptoplasty surgeries
Official scientific title Effects of Oral Clonidine versus Pregabalin on smooth emergence from sevoflurane in adults undergoing rinoseptoplasty surgeries
Brief summary describing the background and objectives of the trial Here we should mention some few lines about sevoflurane anesthesia and the common side effects like agitation ¿¿¿.to assess the safety and effectiveness of oral Clonidine versus Pregabalin for agitation& postoperative pain relief in rinoseptoplasty surgeries with sevoflurane anesthesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied agitation and postoperative pain relief in rinoseptoplasty surgeries with sevoflurane anesthesia.,Ear, Nose and Throat,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 10/09/2017
Actual trial start date 10/09/2017
Anticipated date of last follow up 01/04/2018
Actual Last follow-up date 13/08/2018
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 150
Recruitment status Completed
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oral clonidine group a tablet containing 0.2 mg clonidine once oral 50
Experimental Group oral pregabalin group 150 mg pregabalin capsule once oral 50
Control Group oral placebo group placebo tablets once oral 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I and II patients, scheduled for nasal septoplastic surgeries patients with history of cardiovascular, hepatic or renal disease, chronic pain, history of any kinds used of allergy to clonidine, Pregabalin or other drugs during general anesthesia, history of drug or alcohol abuse and taking clonidine or Pregabalin or ¿ blockers before the surgery except for the study protocol. Also, patients with psychiatric illness or on psychotropic medications are excluded from the study. 18 Year(s) 60 Year(s) Both
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 27/07/2017 Anesthesia Department Ethical Committee
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 decreasing agitation postoperatively in patients undergoing rinoseptoplasty surgeries with sevoflurane anesthesia Riker sedation-agitated scale will recorded at ¿ T0_Before oral premedication as baseline values. ¿ T1_Before induction of anesthesia. ¿ T9_At extubation. ¿ T10-13_At 15, 30, 45, 60 minutes intervals in post anesthesia care period for 1 hour. ¿ measured in the recovery room, every 30 min for 6 hours then at 6, 12 and 24 hours following surgery
Secondary Outcome decreasing postoperative pain in patients undergoing rinoseptoplasty surgeries with sevoflurane anesthesia Postoperative pain by visual analogue score VAS the first record is at 5 minutes after arrival to PACU then measured every 4h until 24 hours following surgery
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
Menoufia University hospital 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
Nadia Mohee Eldin Bahgat Mohammed Husseini street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nadia Bahgat dr_nmbahgat@yahoo.com 00201009558238 Mohammed Husseini street
City Postal code Country Position/Affiliation
Shibin ElKom 002048 Egypt Lecturer of anesthesia and intensive Care, Faculty of Medicine, Menoufia University.
Role Name Email Phone Street address
Public Enquiries Sabry Abdallah sabryabdallah222@yahoo.com 00201012378888 25 Yasin Abd-Elghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Lecturer of anesthesia and intensive Care, Faculty of Medicine, Menoufia University.
Role Name Email Phone Street address
Scientific Enquiries Kalid Gaballa khgaballah@gmail.com 00201016009073 Lotfi Kamal Al Bahari street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Lecturer of anesthesia and intensive Care, Faculty of Medicine, Menoufia University.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol After study completion Researcher controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 10/04/2019 10/04/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 12/11/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks n/a
Changes to trial information