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.: PACTR201710002416280 Date of Approval: 11/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adjuncts to general anesthetics in spine surgery
Official scientific title Perioperative effects of preoperative oral pregabalin or clonidine in patients undergoing lumbar spine posterior fusion
Brief summary describing the background and objectives of the trial Pregabalin and clonidine have anti-nociceptive properties. Acute pain accompanies almost all surgical procedures. Adequate pain relief provides a quick return to normal physiological function and prevents the development of chronic pain. Traditional analgesia in the post-operative period is based on opioids, non-steroidal anti-inflammatory drugs and regional techniques. Administration of high doses of opioids during the post-operative period can result in higher incidence of complications such as respiratory depression, sedation, vomiting, constipation, pruritus, immune dysfunction and urinary retention. NSAIDS may lead to gastrointestinalbleeding, renal toxicity and thromboembolic complications. Pregabalin is a lipophilic gamma-amino-butyric-acid (GABA) analog with anti-convulsant, anxiolyitc and sleep modulating properties. Pregabalin was shown to be effective in neuropathic pain, incisional injury and inflammatory injury. Clonidine is a selective partial alpha2 receptor agonist, which has sedative and anti-nociceptive properties. This study will assess the perioperative effects of oral pregabalin versus clonidine in patients undergoing lumbar spine fusion for stabilization of spondylolisthesis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied adjucts to general anesthetics in spine surgery,Anaesthesia,Nervous System Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/08/2017
Actual trial start date 15/09/2017
Anticipated date of last follow up 01/03/2018
Actual Last follow-up date 15/03/2018
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants) 96
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation 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
Experimental Group Group P pregabalin 300 mg oral capsule, 90 minutes before induction of general anesthesia. once oral premedication 32
Experimental Group Group C clonidine 200 ¿g 90 minutes before induction of general anesthesia. once oral premedication 32
Control Group group A oral placebo drug 90 minutes before induction of general anesthesia. once oral premedication 32 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Adult patients, 18 to 65 years old. ¿American society of anesthesiologists class I or II. ¿Body mass index 25- 40 kg/m2. ¿Normo-tensive patients, systolic blood pressure not more than 140 mmHg and diastolic not more than 90 mmHg. ¿Body mass index more than 40 kg/m2. ¿Previous spine surgery or pain intervention. ¿Poorly controlled arterial hypertension (blood pressure higher than 140/90 mmHg). ¿Respiratory, liver, psychiatric or kidney disease. ¿Heart disease (heart block, or myocardial ischemia). ¿Diabetes mellitus (altered pain perception) ¿Pregnant females. ¿Patients on ¿2 agonist or ¿ blocker therapy. ¿History of hypersensitivity to any of the study drugs. 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 27/06/2017 faculty of medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome anesthetic consumption Propofol induction dose, Intraoperative opioids ( intraoperative fentanyl cosumption will be calculated after recovery) and isoflurane consumption (the end-tidal isoflurane concentrations at BIS value 40 and 50 will be measured and recorded immediately after intubation, then at 10,15,30,60 minutes during procedure).
Primary Outcome intraoperative blood loss: blood volume in the suction container and the number of the bloody gauze pads. at the end of surgery, 24 hour readvac content
Primary Outcome hemodynamics : HR, MAP, Need for nitroglycerin, ephedrine or atropine for maintaining the hemodynamics within the predetermined hemodynamics range. Incidence of intraoperative complications as hypotension/ hypertension, tachycardia/ bradycardia. ¿ Before administration of the oral premedication as baseline values. ¿ Sixty minutes after administration of the premedication. ¿ Before induction of anesthesia. ¿ After intubation at 1, 3, 5, then every 5 minutes all through the surgery. ¿ At 10 minutes after extubation. ¿ Immediately in PACU and then every 15 minutes intervals for 1.5 hours.
Secondary Outcome Extubation time Extubation time: minutes from swiching off isoflurane dial untill the patient fulfills the global and respiratory criteria for safe extubation
Secondary Outcome postoperative side effects: Incidence and severity of side-effects such as PONV, shivering, sedation, headache, visual disturbance and respiratory depression once
Secondary Outcome sedation level by Ramsay Sedation Scale baseline (before premedication), before induction of anesthesia at recovery (5minutes after extubation).
Secondary Outcome PACU discharge time (min). once
Primary Outcome postoperative VAS, analgesic consumption, Time for first postoperative analgesia requirement VAS at PACU admission, 1 hour after PACU discharge, then every 2 hours till completing 24 hours. 24 hours ketorolac and pethidine consumption.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
khaled gaballah 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled gaballah khgaballah@gmail.com 00201016009073 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Public Enquiries wesamuddin sultan wesamsultan@gmail.com 00201010122125 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Scientific Enquiries wesamuddin sultan wesamsultan@gmail.com 00201010122125 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
REPORTING
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