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.: PACTR202402621085427 Date of Approval: 05/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Comparative Evaluation Of Propofol Versus Dexmedetomidine Effects On Haemodynamic Responses, Seizure Duration And Recovery Profile Following Electroconvulsive Therapy
Official scientific title A Comparative Evaluation Of Propofol Versus Dexmedetomidine Effects On Haemodynamic Responses, Seizure Duration And Recovery Profile Following Electroconvulsive Therapy
Brief summary describing the background and objectives of the trial BACKGROUND Anaesthetists may be occasionally needed to provide anaesthesia or sedation in locations outside the operating room. These locations may include psychiatry unit for electroconvulsive therapy, endoscopy unit, radiology unit and others. The anaesthetists should always prepare for the peculiar challenges associated with nonoperating room anaesthesia. Electroconvulsive therapy (ECT) is the induction of generalized tonic clonic seizure by application of electrical shocks of varying frequencies to one or both cerebral hemispheres through electrodes placed on the temporal area of the scalp. This is a safe and effective non-pharmacologic treatment method for many psychiatric disorders such as major depressive disorder, bipolar disorder, mania, catatonia, psychosis and others. It is also considered as the best and fastest treatment option for psychiatric disorders that are resistant to psychotherapy and pharmacotherapy. The clinical effectiveness of propofol versus dexmedetomidine is yet to be compared among Nigerian cohorts. No literature in Nigeria, to the best of the researcher’s knowledge, has compared the effects of propofol versus dexmedetomidine on haemodynamic responses, and seizure duration and recovery profile following electroconvulsive therapy. OBJECTIVES 1. To compare the haemodynamic changes (HR, MAP, SpO2) following the administration of propofol versus dexmedetomidine for electroconvulsive therapy. 2. To compare the duration of seizure following the use of propofol versus dexmedetomidine for electroconvulsive therapy. 3. To compare the recovery profile (time to eye opening, time to obeying command, and presence of agitation by patients) of propofol versus dexmedetomidine when used for electroconvulsive therapy anaesthesia. 4. To compare post-ECT pain using Pain Assessment in Advanced Dementia (PAINAD) scale in both groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 18/02/2024
Actual trial start date
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants)
Recruitment status Not yet 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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group PROPOFOL 1MG/KG 10 MINUTES For patients in propofol group (Group P), 1 mg/kg propofol withdrawn in 20 ml syringe will be injected after waiting for 10 min and the syringe will be hidden from the second assistant. For patients in dexmedetomidine group (Group D), 1 µg/kg dexmedetomidine diluted in 20 ml syringe will be injected over 10 min and the syringe will be hidden from the second assistant. All patients will be administered IV 0.5 mg/kg suxamethonium immediately after induction of anaesthesia. Prior to administration of suxamethonium, a tourniquet cuff which had been applied on the arm without the cannula will be inflated 30 mmHg above the systolic blood pressure and sustained. This is to protect the forearm from being paralyzed by suxamethonium and allow motor seizures to be monitored. Patients will be ventilated briefly with 100% O2, still using facemask and Bain circuit until fasciculation stops. A locally adapted bite block will be inserted to prevent tongue laceration. The facemask will be fastened with harness hook and straps. 38 Active-Treatment of Control Group
Experimental Group dexmedetomidine 1 µg/kg 10 MINUTES For patients in dexmedetomidine group (Group D), 1 µg/kg dexmedetomidine diluted in 20 ml syringe will be injected over 10 min and the syringe will be hidden from the second assistant. All patients will be administered IV 0.5 mg/kg suxamethonium immediately after induction of anaesthesia. Prior to administration of suxamethonium, a tourniquet cuff which had been applied on the arm without the cannula will be inflated 30 mmHg above the systolic blood pressure and sustained. This is to protect the forearm from being paralyzed by suxamethonium and allow motor seizures to be monitored. Patients will be ventilated briefly with 100% O2, still using facemask and Bain circuit until fasciculation stops. A locally adapted bite block will be inserted to prevent tongue laceration. The facemask will be fastened with harness hook and straps. 38
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 18 years and above. 2. Patients with American Society of Anesthesiologists (ASA) physical status class I or II. 1. Refusal of Patient or guardian to give written informed consent. 2. Age below 18 years. 3. Patient with ASA > II 4. History of allergy or sensitivity to the study medications. 5. Presence or evidence of raised intracranial pressure. 6. Presence of glaucoma 7. Present or recent myocardial infarction (by history or ECG, lab results). 8. Anticipated difficult airway 9. Systemic hypertension Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 12/07/2023 AMBROSE ALLI UNIVERSITY EKPOMA HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
KM 70 Benin Auchi Road P. M. B 14, Ekpoma Edo State Nigeria EKPOMA 310101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean arterial pressure changes at 1 min 1 MINUTE
Secondary Outcome 1. Haemodynamic changes at 1 min, 5 min, 10 min and 20 min. 2. Seizure duration 3. Recovery time 4. Post-ECT pain score using Pain Assessment in Advanced Dementia (PAINAD) scale 1 min, 5 min, 10 min and 20 min.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Irrua Specialist Teaching Hospital KM 87, Benin Auchi Road, P.M.B. 08, Irrua, Edo state, Nigeria. Irrua 310120 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SELF FUNDED DEPARTMENT OF ANAESTHESIA, IRRUA SPECIALIST TEACHING HOSPITAL IRRUA Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SELF FUNDED DEPARTMENT OF ANAESTHESIA, IRRUA SPECIALIST TEACHING HOSPITAL IRRUA Nigeria This is a self-funded research
COLLABORATORS
Name Street address City Postal code Country
Dr. Irene Akhidenor Department of Anaesthesia, Irrua specialist teaching hospital Irrua Nigeria
Dr Esther Okogbenin Department of Mental Health and Behavioural medicine, Irrua Specialist Teaching Hospital, Irrua. Irrua Nigeria
Dr Osayomanbo Osaheni Department of Anaesthesia, University of Benin Teaching Hospital, Benin City Benin city Nigeria
Dr Julian Ojebo Department of Anaesthesia, Irrua Specialist Teaching Hospital, Irrua Irrua Nigeria
Dr Christian Osemudiamen Igibah Federal Medical Centre, Asaba Asaba Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Benedict Ezeife ezeifeb@yahoo.com +2348100267252 Department of Anaesthesia, Irrua specialist teaching hospital
City Postal code Country Position/Affiliation
Irrua Nigeria Senior resident
Role Name Email Phone Street address
Public Enquiries Christian Igibah igibah@cancad.org +2347059126266 Federal Medical Centre, Asaba
City Postal code Country Position/Affiliation
Asaba Nigeria Research Assistant
Role Name Email Phone Street address
Scientific Enquiries Julian Ojebo ojebojulian@gmail.com +2349020284145 Department of Anaesthesia, Irrua Specialist Teaching Hospital
City Postal code Country Position/Affiliation
Irrua Nigeria Consultant
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. Data will be made available immediately after publication on reasonable request to the PI. Statistical Analysis Plan,Study Protocol Immediately after publication. No end date. Researchers who provide a methodologically sound proposal.
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