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.: PACTR202204558879194 Date of Approval: 28/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Different doses of intrathecal dexmedetomidine used as adjuvant to hyperbaric prilocaine
Official scientific title The impact of different doses of intrathecal dexmedetomidine used as adjuvant to hyperbaric prilocaine in short ambulatory procedures under spinal anaesthesia: a randomized controlled study
Brief summary describing the background and objectives of the trial Spinal anaesthesia is considered a common procedure in day surgery through using lower doseof local anaesthetic techniques and shorter acting local anaesthetics. Prilocaine is a toluidine derivative and intermediate-acting amino amide with local anesthetic properties. Prilocaine stabilizes the neuronal membrane by preferential binding to and inhibiting depolarization of the voltage-gated sodium channel. Hyperbaric Prilocaine has a faster onset of spinal block and faster patient recovery in short procedure in comparison of plain prilocaine. Intrathecal dexmedetomidineis considered an adjuvant as it can extend the duration of the analgesia of local anesthetic in spinal anesthesia through its potency and highly selective α2adrenoceptor agonist, The selectivity of dexmedetomidine to the α2 receptor provides more effective sedative, anxiolytic, analgesic, antihypertensive, and sympatholytic properties with much less unwanted cardiovascular effects from α1 receptor activation, It improves the quality of postoperative anaesthesia andanalgesia.
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 01/12/2021
Actual trial start date 01/01/2022
Anticipated date of last follow up 25/04/2022
Actual Last follow-up date 01/09/2022
Anticipated target sample size (number of participants) 69
Actual target sample size (number of participants) 69
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 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 Group A 0.5 ml of 5 µg dexmedetomidine + 3 ml (50mg) of Prilocaine. once Patients Will receive spinal anesthesia with study solution of 0.5 ml of 5 µg dexmedetomidine + 3 ml (50mg) of Prilocaine. Under complete aseptic conditions, local infiltration will be done with 2 ml of 2% lignocaine using 25 gauge needle in sitting position. Spinal anaesthesia will be performed in the sitting position at L4 -L5 level through a midline approach using a 25-gauge Quincke spinal needle. Then 3ml ofprepared local anesthetic mixture will be injectedslowly according to the selected group. Patients will be turned to supine position with head up position using a billow. 26 Dose Comparison
Experimental Group Group B 0.5 ml of 10 µg dexmedetomidine + 3 ml (50mg) of Prilocaine. once Patients Will receive spinal anesthesia with study solution of 0.5 ml of 10 µg dexmedetomidine + 3 ml (50mg) of Prilocaine. Under complete aseptic conditions, local infiltration will be done with 2 ml of 2% lignocaine using 25 gauge needle in sitting position. Spinal anaesthesia will be performed in the sitting position at L4 -L5 level through a midline approach using a 25-gauge Quincke spinal needle. Then 3ml ofprepared local anesthetic mixture will be injected slowly according to the selected group. Patients will be turned to supine position with head up position using a billow. 26
Experimental Group Group C 0.5 ml of 15 µg dexmedetomidine + 3 ml (50mg) of Prilocaine. once Patients Will receive spinal anesthesia with study solution of 0.5 ml of 15 µg dexmedetomidine + 3 ml (50mg) of Prilocaine. Under complete aseptic conditions, local infiltration will be done with 2 ml of 2% lignocaine using 25 gauge needle in sitting position. Spinal anaesthesia will be performed in the sitting position at L4 -L5 level through a midline approach using a 25-gauge Quincke spinal needle. Then 3ml of prepared local anesthetic mixture will be injected slowly according to the selected group. Patients will be turned to supine position with head up position using a billow. 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adult patients (18-65 years). • Both genders • ASA I-II. • Patients scheduled for elective surgeries under spinal anaesthesia. • Patients with impaired mental status. • Patients with body mass index <18 or > 35 kg/m2. • Patients suffering from coagulation disorders. • Patients with histories of allergic reactions to local anesthetics or dexmedetomidine. • Patients suffering from severe cardiac, respiratory, hepatic, renal or neuropsychiatric disorders. • Patients with histories of chronic use/abuse of sedatives, narcotics, and of alcohol or other drug abuse. 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 25/09/2021 Armed Forces College of Medicine IRB
Ethics Committee Address
Street address City Postal code Country
Ehsan Abd El Kodous street Cairo 11765 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of analgesia pain free interval 30 minutes 2, 4, 6, 12 and 24 hours post-operatively
Secondary Outcome Mean arterial blood pressure 10 min and postoperative 30min in first 2 hours then every 2h in the next 6 hours
Secondary Outcome Duration of motor block immediately postoperative then 30min, 2h,4h and 6h postoperatively
Secondary Outcome Level of postoperative level of sedation by Ramsay sedation scale immediately postoperative then 30min, 2h,4h and 6h postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Armed Forces College of Medicine Ehsan Abd El Kodous Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Armed forces college of Medicine Ehsan Abd El Kodous Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AFCM Ehasan Abd El Kodous Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bassant Abdelhamid bassantmohamed197@yahoo.com +21224254012 Almerag
City Postal code Country Position/Affiliation
Cairo Egypt assisstant professor AFCM
Role Name Email Phone Street address
Scientific Enquiries Eslam Biekhet Eslambiekhet@gmail.com +21123439976 zahraa nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Anestheia resident AFCM
Role Name Email Phone Street address
Public Enquiries Mohamed Zedan mohammedzedan99@gmail.com 01001935006 Ehsan abd el kodous
City Postal code Country Position/Affiliation
Cairo Egypt Assisstant Lecturer AFCM
Role Name Email Phone Street address
Principal Investigator Hesham El Azzazi heshamelazzazi@hotmail.com +201227378686 Ehsan abd el kodous
City Postal code Country Position/Affiliation
Cairo Egypt Chairman of Anesthesiology department AFCM
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Statistical Analysis Plan 2 years 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