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.: PACTR202308566462034 Date of Approval: 23/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pre-operative study the efficacy of nebulized Dexmedetomidine on blunting hemodynamic changes during intubation and pneumoperitoneum in morbid obese patients during laparoscopic bariatric surgery. Randomized double blind control study
Official scientific title Pre-operative study the efficacy of nebulized Dexmedetomidine on blunting hemodynamic changes during intubation and pneumoperitoneum in morbid obese patients during laparoscopic bariatric surgery. Randomized double blind control study
Brief summary describing the background and objectives of the trial Opioid are widely used in anesthesia practice (4). They are used intraoperatively to ensure effective analgesia and to reduce the need for hypnotic agents. They are used postoperatively to control postoperative pain. But the use of opioids perioperatively may produce various undesirable side effects such as respiratory depression, sedation, constipation, ileus and urine retention. Their use may also increase the incidence of postoperative nausea and vomiting (PONV) and its severity .Elevation of intra-abdominal pressure with raised diaphragm causes various adverse effects on the cardiovascular system such as decreased cardiac output, elevated arterial pressure and increased systemic and pulmonary vascular resistance leading to hypertension and tachycardia. Hence; a drug which can blunt hemodynamic responses to laryngoscopy, intubation and pneumoperitoneum without having any adverse effects like respiratory depression and postoperative nausea and vomiting (PONV) was required for the purpose .This clinical trial suggests that the use of dexmedetomidine nebulization in morbidly obese patients suppress the hemodynamic response for tracheal intubation and pneumoperitoneum and perioperatively decrease opioid requirement. This randomized study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation, pneumoperitoneum and opioid consumption in morbidly obese patients undergoing laparoscopic bariatric surgery.
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: Drugs
Anticipated trial start date 01/09/2023
Actual trial start date 01/09/2023
Anticipated date of last follow up 01/12/2023
Actual Last follow-up date 01/12/2023
Anticipated target sample size (number of participants) 90
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group normal saline group preoperative and before starting the operation Patients will be nebulized with 3 ml of 0.9% normal saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position. 45 Placebo
Experimental Group Dexmedetomidine group preoperatively and before starting the operation Patients of this group will be nebulized with dexmedetomidine 1 mcg/kg in 3 ml of 0.9 % saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position. 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-This study will include 90 adult morbidly obese patients of both sex 2- with BMI (30-45), 3-ASA II-III physical status, 4-aged between 20-60 years 5- scheduled for elective laparoscopic bariatric surgery under general anesthesia. 1-Patients' refusal 2-Decompansated hepatic or renal or cardiac disease 3-Expected difficult airway management 4-Uncontrolled hypertension 5-Psychiatric disease 6-Sever pulmonary disease 7-Patient om opioid, alcohol, beta0 blockers or allergy to any of the study drugs. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 26/06/2023 Scientific Research Ethics Committee Kafrelsheikh university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
El Geish street, Kafrelsheikh , Egypt Kafrelsheikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is hemodynamic response to intubation and pneumoperitoneum. after starting operation and after intubation
Secondary Outcome -Preoperative sedation score -Intraoperative fentanyl consumption and propofol consumption for induction. -Time for first use of rescue analgesia postoperatively. -Total opioid consumption in the first 24 hours postoperative. -Any adverse effects as cough, bradycardia and hypotension. post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh University Hospitals El geish street , Kafrelsheikh , Egypt Kafrelsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif Kamal hafez Arafa 12 Tout Angh Amoun street Tanta 3351111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal hafez arafa 12 tout Angh Amiun street Tanta 31527 Egypt Individual
Secondary Sponsor sherif kamal hafez arafa 12 tout Angh Amiun street Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
sherif kamal hafez arafa 12 Tout Angh Amoun street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sherif arafa sherifarafa1020@gmail.com 00201005714014 12 Tout Angh Amiun street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Public Enquiries Amir Abuzikary aabozikry@yahoo.com 00201016326544 23 Mohb street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries sherif arafa sherifarafa1020@gmail.com 00201005714014 12 Tout Angh Amiun street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
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 ( texts, 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