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: www.pactr.org
Trial no.: PACTR201703002122189 Date of Approval: 22/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Extending spinal anesthesia: dexmedetomidine plus fentanyl
Official scientific title Spinal anesthesia for Lengthy lower limb orthopaedic surgeries: Dexmeditiomidine plus Fentanyl
Brief summary describing the background and objectives of the trial Definitely, we will omit single dose spinal anesthesia for lengthy lower limb orthopedic procedures. While Intrathecal (IT) Bupivacaine lasts only 2-3 hours, Addition of Fentanyl or Morphine has little increased sensory block but did not extend motor block time. In contrast Dexmedetomidine prolongs the duration of sensory and motor blockade in a dose dependent manner covering more than 6 hours in a dose of 10 microgram (mcg).The combined IT administration of both opioids and dexmedetomidine showed synergistic analgesic interaction in animals and humans. IT addition of 5 mcg dexemedetomidine (D) to 10 mcg fentanyl prolonged the duration of analgesia and decreased the incidence of side effects for labour analgesia. While adding 25 mcg Fentanyl to 5 mcg Dexmedetomidine showed no benefit in major abdominal surgery.The combined IT administration of 10 mcg dexmedetomidine plus 25 mcg Fentanyl to our knowledge is not reported before. Our proposal is that, this combination may extend spinal anesthesia to be suitable for long orthopedic procedures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,lengthy lower limb surgeries,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 07/03/2017
Actual trial start date 07/03/2017
Anticipated date of last follow up 30/05/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 63
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R/17.01.97 Institutional Review Board, Faculty of Medicine, Mansoura university, Egypt
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 Computer generated randomization closed envelop method 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 Dexmedetomidine Group Intrathecal 10 micrograme Dexmedetomidine + 20 mg Bupivacaine 24 hours control group 22 Active-Treatment of Control Group
Experimental Group Dexmedetomidine plus Fentanyl Group Intrathecal 10 micrograme Dexmedetomidine + 25 microgram Fentanyl + 20 mg Bupivacaine 24 hours combined Dexmedetomidine plus Fentanyl 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patients scheduled for major lower limb orthopedic procedures exceeding 4 hours as bilateral both lower limbs procedures or two procedures in one lower limb with possible bone grafting. ¿ ASA I-III. ¿ Both sexes. ¿ Patient refusal. ¿ Hypersensitivity to used anesthetics, ¿ General contraindications to spinal anesthesia, ¿ Cardiac, hepatic, renal or respiratory failure. ¿ Difficult communication. 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 06/03/2017 Institutional Research Board (IRB), faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
faculty of medicine, Building A, first floor Mansoura 002050 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ The time till first pain sensation. either intra or postoperatively
Primary Outcome ¿ The time till Bromage score 0 (full leg movement) intra or postoperatively
Secondary Outcome ¿ The required doses of intraoperative iv midazolam, fentanyl and propofol. intraoperatively
Secondary Outcome ¿ The rate of conversion to general anesthesia. intraoperatively
Secondary Outcome Intraoperative hemodynamics (MBP, HR) every 30 min
Secondary Outcome postoperative hemodynamics (MBP, HR) postoperative every 6 h.
Secondary Outcome Maximum and minimum MBP and HR intraoperatively.
Secondary Outcome Required doses of atropine and ephedrine intraoperatively
Secondary Outcome Incidence of using oxygen face mask (SaO2 less than 90%). intraoperatively
Secondary Outcome estimated blood loss intraoperatively
Secondary Outcome The number of packed RBCs transfusion units intraoperatively
Secondary Outcome The volume of fluids administration intraoperatively
Secondary Outcome Incidence of shivering, itching, nausea & vomiting intraoperatively
Secondary Outcome Incidence of sedation, shivering, itching, nausea & vomiting intraoperatively
Secondary Outcome The total morphine requirements during first 24 h postoperatively
Secondary Outcome Visual analogue scale (VAS) every 6 h for 24 h postoperatively.
Secondary Outcome Duration of hospital stay postoperatively
Secondary Outcome Patient satisfaction in a score (0 - 10) after 24 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital Al Gomhouria street Mansoura 002050 Egypt
Delta Hospital gehan street, in front of Emergency Hospital Mansoura 002050 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mansoura university hospital Al Gomhouria street Mansoura 002050 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Al Gomhouria street Mansoura 002050 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed A. Ghanem. faculty of medicine , al Gomhouria street Mansoura 002050 Egypt
Yahya Basyoni faculty of medicine , al Gomhouria street Mansoura 002050 Egypt
Mohamed Serry faculty of medicine , al Gomhouria street Mansoura 002050 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Mazy alaa_mazy@yahoo.com 002050 01140065052 Nansoura faculty of medicine
City Postal code Country Position/Affiliation
Mansoura 002050 Egypt associate profesor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Alaa Mazy alaa_mazy@yahoo.com 002050 01140065052 mansoura faculty of medicine
City Postal code Country Position/Affiliation
Mansoura 002050 Egypt associate profesor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Alaa Mazy alaa_mazy@yahoo.com 002050 01140065052 faculty of medicine, Al Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 002050 Egypt associate profesor of anesthesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 28/03/2017 edit extending spinal anesthesia: dexmedetomidine plus fentanyl Extending spinal anesthesia: dexmedetomidine plus fentanyl
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 27/03/2017 added 2017-05-30
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 18/08/2017 6 patients refused spinal anesthesia 9 patients had short operative procedures than 4h. one difficult spinal one added general anesthesia for upper limb procedure. 63
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 18/08/2017 lengthy is more informative and defined than major Spinal anesthesia for major lower limb orthopaedic surgeries: Dexmeditiomidine plus Fentanyl Spinal anesthesia for Lengthy lower limb orthopaedic surgeries: Dexmeditiomidine plus Fentanyl
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 06/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 06/07/2018 pactr update Other Surgery, Other, Anaesthesia