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.: PACTR201710002669205 Date of Approval: 06/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of Addition of Dexmeditomidine or Fentanyl to Bupivacaine Lumbar Spinal Subarachnoid Anesthesia for Inguinal Hernioplasty
Official scientific title Influence of Addition of Dexmeditomidine or Fentanyl to Bupivacaine Lumbar Spinal Subarachnoid Anesthesia for Inguinal Hernioplasty.
Brief summary describing the background and objectives of the trial Background: No drug, used as adjuvant to spinal bupivacaine has yet been identified that specifically inhibits nociception without its associated side effects. Objectives: The purpose of this study is to compare the efficacy of dexmedetomidine and fentanyl with spinal bupivacaine in inguinal hernioplasty.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,suarachnoid, anesthesia, inguinal, hernioplasty
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2017
Actual trial start date 07/10/2017
Anticipated date of last follow up 01/04/2018
Actual Last follow-up date 04/04/2018
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 60
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 dice-rolling 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 hyperbaric bupivacaine with normal saline 15 mg bupivacaine plus 0.5ml normal saline subarachnoid injection 20 Active-Treatment of Control Group
Experimental Group hyperbaric bupivacaine plus dexmeditomidine 15 mg bupivacaine plus 10 ug dexmeditomidine in 0.5ml normal saline subarachnoid injection 20
Experimental Group hyperbaric bupivacaine plus fentanyl 15mg bupivacaine plus 25 ug fentanyl (0.5ml) subarachnoid injection 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I and II male patients aged 18-50 years height 160-190 weight 50-90 kg scheduled for inguinal hernioplasty under spinal anesthesia patients with a history of cardiac disease uncontrolled hypertension patients with allergy to the study drugs opium addiction sedative drugs consumption contraindications for spinal anesthesia. 18 Year(s) 50 Year(s) Male
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
No 10/10/2017 zagazig medical faculty
Ethics Committee Address
Street address City Postal code Country
zagazig university zagazig 44519 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 31/10/2017 Zagazig Medical faculty
Ethics Committee Address
Street address City Postal code Country
zagazig university zagazig 44519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome onset of anesthesia onset of sensory anesthesia in minutes onset of motor anesthesia in minutes
Primary Outcome duration of anesthesia Regression times in minutes of sensory blocks to S1 segment for sample groups Regression times in minutes of motor blocks to Bromage O for sample groups
Primary Outcome postoperative analgesia 24 hours analgesics consumption in study groups
Secondary Outcome sedation, hypotension, nausia, vomiting, tachycardia, bradycardia, pruritis the need for additional intraoperative analgesics all these parameters were monitored for 24 hours after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
zagazig university hospitals zagazig university zagazig 44519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
zagazig university hospitals zagazig university zagazig 44519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor zagazig university hospitals zagazig university zagazig 44519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Osama Yehia A. Khalifa anesthesia department, zagazig university zagazig 44519 Egypt
Ayman Eskander T. Saadalla anesthesia department, zagazig university zagazig 44519 Egypt
Jehan Fawzy anesthesia department, zagazig university zagazig 44519 Egypt
Heba Fathy anesthesia department zagazig university zagazig 44519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator osama khalifa yehia2001@hotmail.com 00201007579438 anesthesia department, medical faculty, Zagazig university
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Jehan Fawzy fawzyezz@yahoo.com 00201066525038 anesthesia department, zagazig medical faculty, zagazig university
City Postal code Country Position/Affiliation
zagazig 44519 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Ayman Eskander saadalla osamayehiaahmadkhalifa@gmail.com 00201122902202 anesthesia department, zagazig medical faculty, zagazig university
City Postal code Country Position/Affiliation
zagazig 44519 Egypt
REPORTING
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Result URL Hyperlinks
Changes to trial information