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.: PACTR202001644289774 Date of Approval: 31/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Controlled Hypotension in Adult patients undergoing Nasal Surgery, Comparative Study between Remifentanil versus Dexmedetomedine
Official scientific title Controlled Hypotension in Adult patients undergoing Nasal Surgery, Comparative Study between Remifentanil versus Dexmedetomedine
Brief summary describing the background and objectives of the trial Many pharmacologic agents can be used to induce hypotensive anesthesia for nasal surgeries, but which one is the most appropriate is still debatable subject. Total intravenous anesthesia using propofol and inhalational anesthetics using isoflurane were used before as hypotensive agents for nasal surgeries. Nitroglycerine was given to induce hypotensive anesthesia for nasal surgeries. Other drugs included magnesium sulphate, and opioids as remifentanil were recently used. Also, beta blockers as esmolol and dexmedetomedine were used to induce hypotensive anesthesia for nasal surgeries in children and adults. The aim of our study is to compare and evaluate the use of remifentanil (a potent, short acting synthetic μ opioid receptor agonist) and dexmedetomedine (an α2-adrenergic receptor agonist) to induce hypotensive anesthesia, as regard effects and potential adverse effects for nasal surgeries in adults.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 19/01/2020
Actual trial start date
Anticipated date of last follow up 18/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group D 0.5 ug/kg/hour till the end of operation Dexmedetomedine (group D): 40 patients to whom dexmedetomedine infusion will be started at a rate of 0.5 ug/kg/hour, then will be set according to blood pressure response to maintain the mean arterial blood pressure between 60 – 70 mmHg to induce intraoperative controlled hypotension. 40
Control Group Group R 0.2 ug/kg/hour till the end of the operation Remifentanil group (group R): 40 patients to whom remifentanil infusion will be administered at a rate of 0.2 ug/kg/hour, then will be set according to blood pressure response to maintain the mean arterial blood pressure between 60 – 70 mmHg to induce intraoperative controlled hypotension. 40 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 20 to 60 years old, ASA physical status I & II, Scheduled for nasal surgeries [as septoplasty, rhinoplasty, and FESS (Functional Endoscopic Sinus Surgery)] Those with bleeding disorders; coagulopathy, on anticoagulant. Also patients with uncompensated cardiac problems (uncontrolled hypertension, ischemic heart disease, or bradyarrhythmia), hepatic patients with uncompensated respiratory, hepatic, or renal impairment, morbidly obese, patients with neurologic disorders (uncooperative or can’t understand the study protocol). Patients who refuse the study plan, patients with history of allergy to medications used in the study protocol. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 17/07/2017 Approval of the clinical study by the ethics committee
Ethics Committee Address
Street address City Postal code Country
El-Seel street Aswan 81511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome of the study included clarity and dryness of the surgical field estimated every ten minutes by the surgeon. estimated every ten minutes by the surgeon.
Secondary Outcome Secondary outcome of the study included the duration of controlled hypotension, total dose of hypotensive agent used (remifentanil or dexmedetomedine), duration of surgery, duration of anesthesia, time till extubation. Postoperative adverse effects as nausea, vomiting, bradycardia or tachycardia, hypotension or hypertension, agitation and postoperative bleeding will be documented and recorded in PACU. every ten minutes intaoperative and postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aswan University Hospital El-Seel street Aswan Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amir Abouzkry ElSayed El-Seel street, Aswan, Egypt Aswan 81511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir Abouzkry El-Seel street Aswan 81511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amir Abouzkry ElSayed El-Seel street, Aswan Aswan 81511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir Abouzkry aabozikry@yahoo.com 00201016326544 El-Seel street
City Postal code Country Position/Affiliation
Aswan 81511 Egypt Lecturer of Anesthesia and intensive care Aswan Faculty of Medicine Aswan University
Role Name Email Phone Street address
Public Enquiries Amir Abouzkry aabozikry@yahoo.com 00201016326544 El-Seel street
City Postal code Country Position/Affiliation
Aswan 81511 Egypt Lecturer of anesthesia and ICU Aswan Universty
Role Name Email Phone Street address
Scientific Enquiries Amir Abouzkry aabozikry@yahoo.com 00201016326544 El-Seel street
City Postal code Country Position/Affiliation
Aswan 81511 Egypt Lecturer of Anesthesia and ICU Aswan University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Clarity and dryness of the surgical field estimated every ten minutes by the surgeon. The duration of controlled hypotension. Total dose of hypotensive agent used (remifentanil or dexmedetomedine). Duration of surgery, duration of anesthesia, time till extubation. Postoperative adverse effects as nausea, vomiting, bradycardia or tachycardia, hypotension or hypertension, agitation and postoperative bleeding will be documented and recorded in PACU Study Protocol 2 years To those who request the data via e-mail of the principal investigator according to the cause of request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information