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.: PACTR201601001408927 Date of Approval: 04/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Emergence agitation after laparoscopic sleeve gastrectomy
Official scientific title Dexmedetomidine infusion for analgesia and prevention of emergence agitation in morbid obese patients undergoing laparoscopic gastric sleeve gastrectomy
Brief summary describing the background and objectives of the trial Emergence agitation can occur following recovery from general anesthesia. The patient may exhibit aggressive behavior, disorientation, agitation and restlessness.If untreated, this complication may result in significant morbidity. Emergence agitation has been poorly investigated in patients undergoing laparoscopic sleeve gastrectomy. The aim of our study is to assess the efficacy of perioperative dexmedetomidine infusion on emergence agitation and quality of recovery after elective laparoscopic sleeve gastrectomy in morbid obese adult patients.
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 01/06/2015
Actual trial start date 01/06/2015
Anticipated date of last follow up 10/01/2016
Actual Last follow-up date 10/01/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 54
Recruitment status 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 created by 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 Group C Normal saline loading dose of 1 µg/kg over 20 minutes followed by normal saline infusion at a rate of 0.5 µg/kg/h. Normal saline infusion is continued at a rate of 0.5 µg/kg/h from induction of anesthesia until extubation, 30 Placebo
Experimental Group Group D dexmedetomidine loading dose of 1 µg/kg over 20 minutes followed by dexmedetomidine infusion at a rate of 0.5 µg/kg/h. dexmedetomidine infusion is continued at a rate of 0.5 µg/kg/h from induction of anesthesia until extubation, The dexmedetomidine was supplied in 2 ml. ampoules of 100 ¿g/ml concentration. Only 100 ¿g was diluted with 99 ml. of normal saline to yield a final concentration of 1 ¿g/ml.This prepared solution was given over 20 minutes before induction of general anesthesia to the randomly selected patients. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-60 morbid obese patients (body mass index from 35-45 kg/m2) -American Society of Anesthesiologist (ASA) physical status: II and III -age: between 20-50 years -sex: both sexes. -operation:elective laparoscopic sleeve gastrectomy under general anesthesia. - history of hypertension (controlled or uncontrolled) - cerebrovascular disease - cardiac disease - respiratory disease - hepatic disease - renal diseases - thyrotoxicosis - allergy to the study drugs. - therapy with vasoactive medications. - positive pregnancy test. - allergy to eggs or soy. - Patients who experienced major complications that may have contributed to a prolonged hospital stay or increased pain (intestinal leak or bleeding for example) 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 04/01/2016 faculty of medicine, ain shams university
Ethics Committee Address
Street address City Postal code Country
Ramses street, Abassia district Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The incidence of emergence agitation and the postoperative pain. the primary outcomes were recorded in the PACU on arrival, at 5 minutes then every 15 minutes for 120 minutes.
Secondary Outcome The secondary outcome measures were postoperative hemodynamics, postoperative rescue analgesics and postoperative nausea and vomiting. the secondary outcomes were recorded in the PACU on arrival, at 5 minutes then every 15 minutes for 120 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospital Ramses street, Abassia district Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faulty of medicine, ain shams university Ramses street, Abassia district Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faulty of medicine, ain shams university Ramses street, Abassia district Cairo 11566 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mostafa Mansour Houssein 5 Abdelazem Salama street, of Makram Ebed street, Nasr City. Cairo Egypt
Reham Hassan Mostafa 12 3rd setellment, new cairo cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Mansour mostafa_mansour361@hotmail.com 00201093322145 5 abdel azem salama, nasr city
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries mostafa mansour mostafa_mansour361@hotmail.com 00201093322145 5 abdel azem salama, nasr city
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries Reham Mostafa rahamhasan1@gmail.com 00201222530020 3rd setellment, new cairo
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia and intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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