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.: PACTR201604001510193 Date of Approval: 07/03/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of perioperative Dexmedetomidine infusion on blood glucose levels in non diabetic morbid obese patients undergoing laparoscopic bariatric surge
Official scientific title Effect of perioperative Dexmedetomidine infusion on blood glucose levels in non diabetic morbid obese patients undergoing laparoscopic bariatric surgery
Brief summary describing the background and objectives of the trial Anesthesia and surgery¿induced neuroendocrine stress response can be modulated by appropriate premedication. The present study was designed to assess the clinical efficacy of dexmedetomidine premedication for modulation of neuroendocrine stress response by analyzing the perioperative variation of blood glucose level during laparoscopic bariatric surgery. Dexmedetomidine, an ¿2 agonist, when used as an adjuvant in general anesthesia attenuates stress response to various noxious stimuli, maintains perioperative hemodynamic stability and provides sedation without significant respiratory depression postoperatively
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2016
Actual trial start date 01/02/2016
Anticipated date of last follow up 30/04/2016
Actual Last follow-up date 30/04/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Closed to recruitment,follow-up continuing
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexmedetomidine group loading dose: 1 microgram/kg then maintenance dose 0.5 microgram/kg 2 hours Dexmedetomidine effect on random blood sugar 30 Placebo
Control Group Control group Normal saline in same volume and cocentration as in the dex 2 hours Control group 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status II and III of either sex aged 20-50 years BMI ranging from 35-55 kg/m2 cardiac, pulmonary, hepatic, renal, or metabolic disorders receiving medications that might affect sympathetic response or hormonal secretions. Also, none have other Endocrine disorders that affect blood glucose levels such as Cushing syndrome and Hyperthyroidism or are receiving drug therapy significantly affecting blood glucose level such as Corticosteroid therapy. Patients with history of allergy to the study drugs, therapy with vasoactive medications or positive pregnancy test were excluded from the study Also, patients with allergy to eggs or soy were excluded. Complicated surgeries of more than 2 h were also excluded 20 Year(s) 50 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
No 15/03/2016 Ain Shams university Ethical committee of Scientific Research
Ethics Committee Address
Street address City Postal code Country
Abbasia Cairo N/A Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome investigate the influence of dexmedetomidine premedication on modulation of neuroendocrine stress response during laparoscopic bariatric surgery under general anesthesia by analyzing the variation of perioperative serial blood glucose levels Perioperative blood glucose levels were analyzed preoperatively, at 30 min after beginning of surgery then every hour till end of surgery, and 6 h after surgery
Secondary Outcome All patients were also assessed for intraoperative hemodynamic changes of heart rate and mean arterial pressure at specific timings, intraoperative sevoflurane requirements and narcotic consumption. The secondary outcome measures were intraoperative hemodynamics, narcotic consumption and sevoflurane consumption in addition to postoperative side effects
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Abbasia Cairo N/A Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal Abbasia Cairo N/A Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Raham Hasan Abbasia Cairo N/A Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Raham Hasan Abbasia Cairo N/A Egypt
Ibrahim Mohammed Abbasia Cairo N/A Egypt
Ahmed Hany Nasr City Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Raham Hasan rahamhasan@yahoo.com N/A Abbasia
City Postal code Country Position/Affiliation
Cairo N/A Egypt Lecturer of Anesthesia
Role Name Email Phone Street address
Public Enquiries Ahmed Hany rahamhasan@yahoo.com +02 01005128527 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Mohammed rahamhasan@yahoo.com +02 01001430952 Dokky
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams University
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information