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.: PACTR201806003461321 Date of Approval: 12/06/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title analgesic Effect of clozapine in Abdominal surgery
Official scientific title Effect of clozapine as apreemptive analgesia in Patients Undergoing Abdominal Hysterectomy
Brief summary describing the background and objectives of the trial Clozapine is a dibenzodiazepine derivative with a pharmacological and therapeutic profile that distinguishes it from the classic antipsychotics . c1ozapine differs from the typical antipsychotics in producing relatively weak antagonism at central dopamine D2 receptors, more pronounced inhibition of dopamine DI mediated activation of adenylate cyclase, and potent blockade of central serotonergic, adrenergic and cholinergic receptors.Using the mouse tail-flick assay, the antinociceptive effect and the interaction with the opioid, adrenergic, and serotonergic systems of clozapine was evaluated. It was found that Clozapine induced a potent antinociceptive effect in a dose-dependent manner with ED50 of 8.7 mg/kg, and this effect was antagonized by the nonselective opioid antagonist naloxone, implying an opioid mechanism of action involved in clozapine-induced antinociception.this study will assess and compare the effect of clozapine as a preemptive analgesia in patients undergoing abdominal hysterectomy surgeries under general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied abdominal hysterectomy surgeries,Obstetrics and Gynecology,Surgery
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2018
Actual trial start date
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet 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 randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group clozapine group 25 mg of clozapine once preoperative Patients will receive oral clozapine as a premedication, 30 minutes preoperative.standard monitoring .induction of anesthesia with propofol 2mg/kg, fentanyl 1µg/kg and Cisatracium 1mg/kg and maintenance with isoflurane.fentanyl 0.5 µg/kg will be given if hypertension or tachycardia more than 20% of the patient base line occurs ,then reversal of muscle relaxant at the end of surgery 30
Control Group control group placebo once preoperative Patients will receive oral placebo as a premedication, 30 minutes preoperative.standard monitoring .induction of anesthesia with propofol 2mg/kg, fentanyl 1µg/kg and Cisatracium 1mg/kg and maintenance with isoflurane.fentanyl 0.5 µg/kg will be given if hypertension or tachycardia more than 20% of the patient base line occurs ,then reversal of muscle relaxant at the end of surgery 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Adults more than 21 years and less than 60 years of age undergoing abdominal hystrectomy 2-Patients are ASA I (American Society of Anesthesiologists physical status Grade I) = (normal healthy patients), ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations) 3-Abdominal hysterectomy under general anesthesia 4-Patients of Body Mass Index (BMI) ¿ 20 and ¿ 30 1-Refusal of participation in the study 2-A known history of sensitivity to clozapine 3-Schizophrenia or other psychiatric disorder (a previous diagnosis of any psychiatric disorder listed in Diagnostic and Statistical Manual of Mental Disorders IV), history of untreated non-psychotic emotional disorders, cognitive impairment or any difficulties with communication that will impair or interfere with Peri-operative and assessment procedures 4-History of drug dependency or substance addiction Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 60 Year(s) Female
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 20/04/2016 research ethics committee ,faculty of medicine,suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4,5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome intraoperative analgesic requirements allover surgical procedure
Secondary Outcome preoperative sedation using Riker Sedation-Agitation Scale before induction of anesthesia
Secondary Outcome heart rate every 15 mins
Secondary Outcome mean arterial blood pressure every 15 mins
Secondary Outcome duration of surgery from skin incision to skin closure at the end of surgery
Secondary Outcome Total intraoperative mean isoflurane consumption at the end of surgery
Secondary Outcome postoperative recovery using modified Aldrete score every 15 mins after emergence from anesthesia
Secondary Outcome post-perative sedation using Riker Sedation-Agitation Scale every 15 mins after emergence from anesthesia
Secondary Outcome Time of first analgesic request after recovery from anesthesia
Secondary Outcome 24 hours morphine consumption by PCA after 24 hours of surgery
Secondary Outcome Adverse effects: dizziness, insomnia, unresponsiveness, agitation, airway obstruction, respiratory depression, or nausea and vomiting after the the end of surgery for 24 hours
Secondary Outcome postoperative VAS score at rest every 1hour after surgery
Secondary Outcome postoperative VAS score at movement every 1 hour after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital ring road kilo4,5 ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding sources
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor departemnt of anesthesia ,faculty of medicine ,suez canal university ring road kilo4,5 ismailia 41522 Egypt Charities/Societies/Foundation
Primary Sponsor suez canal university hospital ring road kilo4,5 ismailia 41522 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
hamdy ali hendawy hoda sharawy st ismailia 41522 Egypt
mohamed abuelnaga ard elgameiat ,elsheikh zayed ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hamdy hendawy hamdyhendawy@gmail.com 002-01143667734 hoda sharawy st
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia and intensive care ,faculty of medicine ,suez canal university
Role Name Email Phone Street address
Public Enquiries mohamed abuelnaga Mohamed_abuelnga@med.suez.edu.eg 002-01004150671 ard elgameiat,elshikh zayed
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia and intensive care ,faculty of medicine ,suez canal university
Role Name Email Phone Street address
Scientific Enquiries mohamed abuelnaga Mohamed_abuelnga@med.suez.edu.eg 002-01004150671 ard elgameiat,elshikh zayed
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia and intensive care ,faculty of medicine ,suez canal university
REPORTING
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