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.: PACTR202203767098081 Date of Approval: 15/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Opioid free Anesthesia versus Balanced Anesthesia with Fentanyl for Laparoscopic Bariatric Surgeries
Official scientific title Balanced Opioid free Anesthesia with Dexmedetomidine versus Balanced Anesthesia with Fentanyl for Laparoscopic Bariatric Surgeries: A Prospective Randomized Study
Brief summary describing the background and objectives of the trial The goals of avoiding opioids in the surgical population include the reduction or prevention of opioid induced hyperalgesia (OIH), respiratory depression, central muscle rigidity, pharyngeal muscle weakness, obstructed breathing, nausea, vomiting, ileus, constipation, urinary retention, Tolerance and addiction, dizziness, excessive somnolence, possibility of inferior outcomes in oncology The aim of this present study is to determine whether opioid-free balanced anesthetic with dexmedetomidine reduces postoperative opioid consumption and related adverse events
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/03/2022
Actual trial start date
Anticipated date of last follow up 04/09/2022
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Fentanyl group IV fentanyl 25-50 mcg iv boluses Intraoperative Anaesthesia will be induced with lidocaine 1.5 mg/kg iv, propofol 2 mg/kg, ketamine 25 mg and cisatracurium besylate 0.15 mg/kg for intubation, anesthesia will be maintained with sevoflurane in 50% air and cisatracurium 0.03 mg/kg guided with nerve stimulator Enrolled patients will be assigned to mange inadequate anti nociception either by IV fentanyl 25-50 mcg iv boluses 30 Active-Treatment of Control Group
Experimental Group dexmedetomidine group IV dexmedetomidine administered at the infusion rate of 0.25 to 1 mcg/kg/h Intraoperative Anaesthesia will be induced with lidocaine 1.5 mg/kg iv, propofol 2 mg/kg, ketamine 25 mg and cisatracurium besylate 0.15 mg/kg for intubation, anesthesia will be maintained with sevoflurane in 50% air at minimum alveolar concentration (MAC) 2% and cisatracurium 0.03 mg/kg guided with nerve stimulator. Enrolled patients will be assigned to mange inadequate anti nociception by IV dexmedetomidine administered at the infusion rate of 0.25 to 1 mcg/kg/h 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- adult patients of both sexes, -aged 18-60 years old, -classified by the American society of anesthesiologists as ASA II and III -Patients refusal, - renal or hepatic insufficiency, -chronic opioid or beta blocker use - known allergy to study drugs - patients with atrioventricular block type II & III. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 15/01/2022 Research Ethics Committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El Geish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative opioid consumption once within 24 hours
Secondary Outcome . Postoperative pain postoperative nausea and vomiting (PONV) postoperative pain will be measured at when the patient awake and 30 minutes and 1, 6, 12 and 24 hours after surgery, while PONV will be measured once during 24 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals El Geish Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dina Ahmed El Malla El Geish Tanta 31527 Egypt
Ahmed Mohamed Fetouh Abdelrahman El Geish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdelrhman ahmed.abdelrahman@med.tanta.edu.eg 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Public Enquiries Dina El Malla dr_dina90@yahoo.com 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abdelrahman ahmed.abdelrahman@med.tanta.edu.eg 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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