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.: PACTR201710002516280 Date of Approval: 14/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pregabalin and Hypotensive Anesthesia
Official scientific title Pregabaline Effects on Hypotensive Anesthesia during Spine Surgery.
Brief summary describing the background and objectives of the trial Elective lumbar spine surgical procedures are commonly performed under controlled hypotension during general anesthesia. That is to limit the blood loss and transfusions and improves surgical field. Deliberate hypotension could be achieved via various medications. Pregabalin effectively augmented hypotensive anesthesia during sinus surgery. Pregabalin was effective in neuropathic postoperative pain relief. The aim of the study is to evaluate the effects of Pregabalin regards facilitation of induced hypotension during spine surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,spine surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 07/08/2017
Actual trial start date 07/08/2017
Anticipated date of last follow up 01/11/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 106
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R/17.07.107 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
Experimental Group Pregabalin group 150 mg once, one hour preoperatively oral pregabalin capsule 150 mg (LYRICA® 150 mg capsule- PFIZER) one hour before induction of anesthesia 53 Active-Treatment of Control Group
Control Group general anesthesia only a placebo oral capsule once a placebo oral capsule will be given once one hour before induction of anesthesia 53 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- aged 18¿55 years, - American Society of Anesthesiologists (ASA) score I-II - admitted to undergo elective lumbar discectomy or spinal fixation surgery under general anesthesia - Patients on anti-hypertensive treatment, diuretics, corticosteroids, pregabalin, gabapentin, anticonvulsants, antipsychotics, alcohol addiction, drug abuse or any analgesics within 48 hours before surgery. - patients with history of allergy to any drug used in the study. - pregnant or nursing women. - patients with peripheral neuropathy, endocrinal diseases, bleeding abnormality, cardiac, hepatic or renal impairment. 18 Year(s) 55 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 07/08/2017 Institutional Research Board (IRB), faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
faculty of medicine, Building A, first floor Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraoperative consumption of nitroglycerin to maintain the target MAP 55- 65 mmHg. intraoperatively
Secondary Outcome estimated blood loss intraoperative
Secondary Outcome The number of transfused blood unites intraoperatively
Secondary Outcome heart rate (HR) and invasive MAP - Basal, during intubation, 1 and 5 min after intubation, every 30 min intraoperatively, then at 1 and 2h postoperatively.
Secondary Outcome end-tidal isoflurane concentration Intraoperatively every 30 min
Secondary Outcome Surgeon satisfaction about the field (scale 0-5) at the end of surgery
Secondary Outcome Sedation (by Ramsay sedation scale) at 0, 2, 4, 6, 12 and 24h postoperatively
Secondary Outcome The time to the first request of analgesia. postoperative
Secondary Outcome Postoperative pain (by VAS 0-10 scale) at 0, 2, 4, 6, 12 and 24 h postoperatively.
Secondary Outcome The total morphine consumption in the 1st 24 hours postoperatively.
Secondary Outcome Frequency of adverse effects as dizziness, headache, nausea and vomiting, or pruritus. during the first 24 h postoperatively.
Secondary Outcome Peak and plateau airway pressures after settled prone position
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital Al Gomhouria street Mansoura 35516 Egypt
Delta hospital Jehan street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Al Gomhouria street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine, Mansoura universisty al Gomhouria street Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Maha A. Abo-Zeid Al Gomhouria street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Mazy alaa_mazy@yahoo.com 002050 01140065052 faculty of medicine, Al Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 35516 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 faculty of medicine, Al Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 35516 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 35516 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 35516 Egypt associate profesor of anesthesia and surgical intensive care
REPORTING
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