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.: PACTR202209726231234 Date of Approval: 05/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine (10 μg) versus Fentanyl (25 μg) as adjuvants to hyperbaric Bupivacaine for unilateral spinal anesthesia in lower limb orthopedic surgeries
Official scientific title Dexmedetomidine (10 μg) versus Fentanyl (25 μg) as adjuvants to hyperbaric Bupivacaine for unilateral spinal anesthesia in lower limb orthopedic surgeries
Brief summary describing the background and objectives of the trial Unilateral spinal anesthesia with a low dose of anesthetics and limited volume is suitable for lower limb surgeries because it achieves stable hemodynamics , rapid recovery and prevents unnecessary nerve block in the contralateral limb. On the other side, onset of anesthesia and immobility is slower and duration of sensory and motor block is shorter when compared to bilateral spinal anesthesia . Many drugs such as opioids (morphine, fentanyl), α2 adrenergic agonists (dexmedetomidine , clonidine), magnesium sulfate, neostigmine, ketamine, and midazolam can be used as adjuvants to intrathecal local anesthetics to improve the quality of spinal anesthesia . This study is aiming to compare fentanyl (25 μ) and dexmedetomidine (10 μ) as adjuvants to hyperbaric Bupivacaine in unilateral spinal anesthesia in orthopedic surgeries of lower limb.
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 01/05/2022
Actual trial start date 01/05/2022
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmedetomidine 10 μg the drug will be injected intrathecally with hyperbaric bupivacaine in about 3 seconds A wide bore IV cannula will be inserted, then 10 mL/kg of lactated Ringer's solution will be administered over 20 minutes (min). patients will undergo standard monitoring including heart rate (HR), blood pressure (BP) and oxygen saturation (SO2). patients will be kept fasting for 8 hours prior to surgery. The patients will be placed in lateral decubitus position with operating side (limb) dependent on the operating table, with both hip and knee joints flexed. 2.5 ml of hyperbaric bupivacaine will be loaded aseptically in a 5-ml sterile syringe with 10 μ dexmedetomidine (0.5 ml) The lumbar area will be prepared aseptically and draped. Spinal anesthesia will be performed with 25-gauge spinal needle with midline approach and bevel facing downward. Intrathecal placement of the needle will be confirmed with free flow of cerebrospinal fluid (CSF), and then the drug will be injected intrathecally. patients will be kept in the lateral position for 15 minutes, then will be gently turned to the position required for the surgery. 27
Control Group fentanyl 25 μg the drug will be injected intrathecally with hyperbaric bupivacaine in about 3 seconds A wide bore IV cannula will be inserted, then 10 mL/kg of lactated Ringer's solution will be administered over 20 minutes (min). patients will undergo standard monitoring including heart rate (HR), blood pressure (BP) and oxygen saturation (SO2). patients will be kept fasting for 8 hours prior to surgery. The patients will be placed in lateral decubitus position with operating side (limb) dependent on the operating table, with both hip and knee joints flexed. 2.5 ml of hyperbaric bupivacaine will be loaded aseptically in a 5-ml sterile syringe with 25 μ fentanyl (0.5 ml) The lumbar area will be prepared aseptically and draped. Spinal anesthesia will be performed with 25-gauge spinal needle with midline approach and bevel facing downward. Intrathecal placement of the needle will be confirmed with free flow of cerebrospinal fluid (CSF), and then the drug will be injected intrathecally. patients will be kept in the lateral position for 15 minutes, then will be gently turned to the position required for the surgery. 27 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Age ≥21 years and <65 years. -ASA grade I and II -both sexes -Patients undergoing elective orthopedic surgeries of lower limb. -Any patient who has history of heart failure (NYHA class Ⅲ,Ⅳ), neuropathy , uncontrolled hypertension, drug abuse, or allergy to the study drugs or has any contraindication of spinal anesthesia -Patients who can't be placed in a lateral position (e.g., due to pelvis fracture) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 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 07/11/2021 Research Ethics Committee Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbasia cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome is to measure the time taken for the patient to rescue analgesia up to 7 hours after spinal anedthesia
Secondary Outcome is to measure : • Time from injection to highest sensory level • Time to two segment regression from the highest sensory level • Time for sensory regression to S1 from highest sensory level • Time from injection to Bromage Ⅲ • Time to regression to Bromage 0 • Side effects like nausea, vomiting, shivering or respiratory depression for 4 hours after performing spinal anesthesia • Sedation level will be assessed using modified Ramsay scale till reaching the above criteria
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University hospitals Abbasia cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mariam Gamal Motawashleh 2 Amir El Hag, Ard El Taweel, shobra cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine Ain Shams University 38 Abbasia nearby El Nour mosque cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries mariam gamal gmariam488@gmail.com 00201273393347 2 Amir El Hag, Ard El Taweel, Shobra
City Postal code Country Position/Affiliation
cairo Egypt assisstant lecturer
Role Name Email Phone Street address
Scientific Enquiries azza shafik azza_moh_shafik@hot.com 00201001843218 167 Ahmed Okasha ,1st settelment
City Postal code Country Position/Affiliation
cairo Egypt professor at anesthesia department Ain Shams University
Role Name Email Phone Street address
Principal Investigator Amin Al Alansary aminalansary@yahoo.com 00201271399590 Salah El Eldin
City Postal code Country Position/Affiliation
monofya Egypt assistant professor at anesthesia department Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual data collected during the trial after deidentification Study Protocol following publication any purpose
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