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.: PACTR201909641727181 Date of Approval: 20/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of midazolam and dexmedetomidine for attenuating the hormonal stress response to endotracheal intubation in hypertensive adult patients undergoing elective surgery.
Official scientific title Efficacy of midazolam and dexmedetomidine for attenuating the hormonal stress response to endotracheal intubation in hypertensive adult patients undergoing elective surgery.
Brief summary describing the background and objectives of the trial Aim was to compare the efficacy of midazolam and dexmedetomidine for attenuating the hormonal stress response to endotracheal intubation in hypertensive adult patients undergoing elective surgery.Mean arterial blood pressure MAP, heart rate HR, serum cortisol and norepinephrine NE levels were measured before infusion (baseline T0), before intubation T1, 1 and 5 minutes after intubation (T2&T3).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2018
Actual trial start date 01/01/2018
Anticipated date of last follow up 01/08/2018
Actual Last follow-up date 01/08/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group midazolam group midazolam infusion of 0.04 mg/kg in 0.9% NaCl 100 mL (M group) over 10 minutes before induction of anesthesia receive midazolam infusion of 0.04 mg/kg in 0.9% NaCl 100 mL (M group) over 10 minutes before induction of anesthesia . 20 Active-Treatment of Control Group
Experimental Group dexmedetomidine group dexmedetomidine infusion of 0.75μg/kg in NaCl 0.9% 100 ml over 10 minutes before induction of anesthesia dexmedetomidine infusion of 0.75μg/kg in NaCl 0.9% 100 ml (Dex group) over 10 minutes before induction of anesthesia 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status II & III, aged 18–65 years, scheduled for elective surgery, and known to be hypertensive with good control ( blood pressure lower than 140/90), were included in the study. Patients were excluded if they have known allergy to any of the study drugs, arterial blood pressure more than 140/90, preoperative arrhythmias, tachycardia (heart rate > 100 beats per minute), bradycardia (heart rate < 50 beats per minute), second- or third-degree atrioventricular block, coronary artery disease, , previous cerebrovascular accident, renal or liver impairment, obesity (body mass index>30), and suspected difficult intubation. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 08/12/2017 Medical Ethics Committee of Al Menoufyia University Hospital
Ethics Committee Address
Street address City Postal code Country
gamal abdel naser shebin elkom menofia 51132 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the hemodynamics which includes mean arterial blood pressure (MABP) and heart rate (HR) responses to laryngoscopy and endotracheal intubation
Secondary Outcome biochemical end point through serum cortisol and serum norepinephrine level measurement (reflecting the magnitude of the hormonal stress responses responses to laryngoscopy and endotracheal intubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufyia University Hospital shebeen elkom menoufiya 51132 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine menofeya university faculty of medicine menofeya university sheben el kom sheben el kom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor eman sayed nasser el thawra haram giza giza 1234 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nagwa Mohamed Doha faculty of medicine - Menoufia University -Shebeen Elkom Shebeen Elkom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator eman sayed emansayed825@gmail.com 00201282271464 abdalah esmaeal nasser elthawra
City Postal code Country Position/Affiliation
giza 1234 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries nagwa doha nagwamohameddoha@yaho.com 0001006235642 menofeya
City Postal code Country Position/Affiliation
menoufeya 51132 Egypt associate professor
Role Name Email Phone Street address
Public Enquiries hesham maged heshammaged@yahoo.com 000123548537 giza
City Postal code Country Position/Affiliation
giza 1234 Egypt MD
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will individual participate data and share it through the PubMed indexed journal Study Protocol we will individual participate data and share it through the PubMed indexed journal we will individual participate data and share it through the PubMed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
PubMed indexed journal 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