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.: PACTR201703002150349 Date of Approval: 28/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Aminophylline for recovery from bariatric surgery
Official scientific title Effect of aminophylline on recovery criteria and respiratory parameters following laparoscopic sleeve gastrectomy in morbidly obese suffering from OSA
Brief summary describing the background and objectives of the trial Cumulative evidence suggests that aminophylline given at the end of surgery shortens recovery time from general anesthesia and improves the quality of recovery . Furthermore, aminophylline has been shown to decrease the depth and duration of sedation produced by barbiturates , diazepam , midazolam and Propofol. The injection of aminophylline 3 mg/kg has been shown to be associated with significant increases in bispectral index up to 10 min after its injection, while heart rate and blood pressure did not change. It appears that aminophylline has the ability to partially antagonise the sedative effects of general anaesthetics (11). Morbidly obese patients suffer many respiratory problems including, reduced functional residual capacity, increased shunting and obstructive sleep apnea. These characteristics render them more susceptible to postoperative pulmonary complications such as pulmonary atelectasis, increased sensitivity to opioids, hypoxia and hypercarbia. Amongst these, increased sensitivity to narcotic induced respiratory depression is of particular concern. We hypothesized that aminophylline inection before awakening would speed recovery and decrease respiratory complications for morbidely obese patients with suffering obstructive sleeve apnea undergoing laparoscopic sleeve gastrectomy surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied decrease respiratory complication in obese recovering from sleeve surgery,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2017
Actual trial start date 10/05/2017
Anticipated date of last follow up 04/09/2017
Actual Last follow-up date 24/10/2017
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants) 105
Recruitment status Completed
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 computer generated permuted block randomization of equal size blocks central randomization by phone calls to an anesthesia technician who will not participate in patient care or outcome assessment 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 Aminophylline group 5mg/kg 15 minutes before the end of surgery Aminophylline 5mg/kg will be infused to the patient 15 minutes before the end of surgery, aminophylline diluted to 20 ml by addition of normal saline will be infused 55
Control Group Saline group normal saline 20 ml 15 minutes before the end of surgery normal saline 20 ml will be infused to the patient 15 minutes before the end of surgery 55 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Body mass index equal or more than 40 2- both male and female 3-age between 20 and 60 4- undergoing laparoscopic sleeve gastrectomy 5- suffering from OSA as diagnosed by STOP BANG score 1- Uncontrolled hypertension, myocardial infarction, heart failure. 2- complicated uncontrolled diabetes 3-Active peptic ulcer 4-BMI above 60 5-angina, core pulmonale,tachydysrythmia, 6- seizures, hyperthyroidism, hypothyroidism 7- Pregnancy, Alcoholism, allergy to xanthine compounds. 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 06/02/2017 Menoufia University
Ethics Committee Address
Street address City Postal code Country
Gamal Abdelnasser street Shebin Elkom NA Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to extubation in minutes From the closure of anesthesia vaporizer until removal of the endo-tracheal tube
Secondary Outcome Time to recovery of two twitches of train of four in minutes the time from stppage of muscle relaxant infusion till recovery of two twitches of TOF
Secondary Outcome Time to adequate tidal volume the time from start of spontaneous breathing until attaining a 5 ml/ kg tidal volume
Secondary Outcome time to eye opening the time from closure of anesthesia vaporizer till eye opening to command.
Secondary Outcome incidence of complications 1- incidence of upper airway obstruction 2- the need for CPAP 3- incidence of curarization 4- number of patients need postoperative ventilation 5- postoperative CO2
Secondary Outcome Length of stay in postoperative care unit equals the time of emergence of anesthesia till discharge fro PACU
Secondary Outcome The quality of recovery score will be assessed on postoperative day 3
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menofiya university gama abdelnasser street Shebin Elkom NA Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufiya university gama abdelnasser street Shebin Elkom NA Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufiya university gama abdelnasser street Shebin Elkom NA Egypt University
COLLABORATORS
Name Street address City Postal code Country
hazem elsersy 89 Zaki Shabanah street Shebin Elkom NA Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hazem elsersy hazelsersy@hotmail.com 00201091096655 89 Zaki Shabanah street
City Postal code Country Position/Affiliation
Shebin Elkom NA Egypt lecturer of anesthesia menoufiya university
Role Name Email Phone Street address
Public Enquiries Hazem elsersy hazelsersy@hotmail.com 00201091096655 89 Zaki Shabanah street
City Postal code Country Position/Affiliation
Shebin Elkom NA Egypt lecturer of anesthesia menoufiya university
Role Name Email Phone Street address
Scientific Enquiries Hazem elsersy hazelsersy@hotmail.com 00201091096655 89 Zaki Shabanah street
City Postal code Country Position/Affiliation
Shebin Elkom NA Egypt lecturer of anesthesia menoufiya university
REPORTING
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