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.: PACTR202402608586239 Date of Approval: 21/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Dexmedetomidine Premedication on Attenuation of Stress Response to Laryngoscopy and Endotracheal Intubation
Official scientific title Effect of Dexmedetomidine Premedication on Attenuation of Stress Response to Laryngoscopy and Endotracheal Intubation in Patients Undergoing Elective Surgeries Using Analgesia Nociception Index
Brief summary describing the background and objectives of the trial Laryngoscopy and tracheal intubation lead to tachycardia and hypertension due to increase in the plasma concentration of catecholamine subsequent to sympathetic stimulation. Dexmedetomidine is highly selective central α2adrenergic receptor agonist, It has analgesic, sedative and anxiolytic properties, with a mild inhibitory effect on respiratory function,Analgesia nociception index (ANI) has recently been explored to assess nociception during perioperative period. The ANI is an electrophysiological monitoring tool so the objectives are to Evaluation the effect of two different doses of dexmedetomidine premedication on attenuation of stress response to direct laryngoscopy and endotracheal intubation
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DEX LAR
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 01/01/2024
Actual trial start date 01/01/2024
Anticipated date of last follow up 01/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL IN anasthesia and analgesia journals and pain manegement journals
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dex 1 Dexmedetomidine 0.5mcg/kg diluted in 50 ml of normal saline IV infusion over a period of 10 min as intravenous premedication before induction. receive Dexmedetomidine 0.5mcg/kg diluted in 50 ml of normal saline IV infusion over a period of 10 min as intravenous premedication before induction. 28
Experimental Group DEX2 Dexmedetomidine 1 mcg/kg diluted in 50 ml of normal saline IV infusion over a period of 10 min before induction will receive Dexmedetomidine 1 mcg/kg diluted in 50 ml of normal saline IV infusion over a period of 10 min before induction 28
Control Group control group 50 ml normal saline 10 minutes as premedication befor induction of anasthesia will receive 50 ml normal saline over 10 minutes as premedication. 28 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) Adult patients who will have elective surgical operations under general anesthesia. (2) Age: Patients age 18–65 years, of both sexes. (3) American Society of Anesthesiologists (ASA) grade I–II (4) Body mass index (BMI) 18.5–35 kg/m2. (5) Airway of Modified Mallampati Grade I and II (1) Patient refusal to participate in the study. (2) Morbid obesity Body mass index higher than 35 kg/m2 (3) Patients with pacemakers and cardiac arrhythmia. (4) Uncontrolled diabetes mellitus, hypertension, ischemic heart disease, , history of myocardial, pulmonary, or endocrine diseases, , hepatic or renal impairment. (5) Pregnancy, full stomach, emergency surgery. (6) Patients who are allergic to any of the study drugs, those with opioid addiction. (7) Patients on beta blocker or calcium channel blocker. (8) Patients who had Cormack Lahane score III and above and also those in which the duration of laryngoscopy lasted more than 25 seconds. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 01/01/2024 institutional review board
Ethics Committee Address
Street address City Postal code Country
yaseen abdelghafar shebeen elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome compare changes in analgesia nociception index [ANI] during direct laryngoscopy and endotracheal intubation in patients undergoing elective surgeries after premedication by dexmedetomidine in two different doses before insertion of laryngoscope , during laryngoscopy and at 1, 2, 3, 4 , 5 ,6,7 and 10 minutes after intubation.
Secondary Outcome to find out the optimum dose of dexmedetomidine given as premedication according to changes in the ANI correlated to hemodynamics before insertion of laryngoscope , during laryngoscopy and at 1, 2, 3, 4 , 5 ,6,7 and 10 minutes after intubation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NAtional liver institute yassen abdelghafa street shebeen elkom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yaseen abdelghafar shebeen elkom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor natioanl liver institute yassen abdelghafar shebeen elkoom 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator dina El Fawal dinaelfawal94@gmail.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt teaching assisstant
Role Name Email Phone Street address
Scientific Enquiries dina El Fawal dinaelfawal94@gmail.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt teaching assisstant
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt lecturer of anasthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend sharing study protocol , aim of the work, patient and method and the results when be available.sharing of de-identified individual trial participant data. effect dexmedetomidine on patient haemodynamics Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol when the study completed, and the results will be available search by Dexmedetomidine Premedication
URL Results Available Results Summary Result Posting Date First Journal Publication Date
international anasthesia and analgesia 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