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Trial registered on ANZCTR


Registration number
ACTRN12616001233415
Ethics application status
Approved
Date submitted
23/01/2016
Date registered
5/09/2016
Date last updated
5/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Comparative Study of Clonidine and Magnesium sulfate Premedication on peri operative hormonal stress responses, hemodynamic stability and postoperative analgesia in Laparoscopic Cholecystectomy
Scientific title
A comparative study of clonidine and magnesium sulfate premedication on peri operative hormonal stress responses, hemodynamic stability and postoperative analgesia in patients with gallbladder diseases undergoing laparoscopic cholecystectomy: A randomized, double-blind, controlled study
Secondary ID [1] 288080 0
Nil
Universal Trial Number (UTN)
U1111-1177-2972
Trial acronym
C . Vs. Mgso4 in LC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anesthetic management of patients with gallbladder diseases undergoing laparoscopic cholecystectomy . 296942 0
Condition category
Condition code
Anaesthesiology 297188 297188 0 0
Anaesthetics
Surgery 297868 297868 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 groups are included in which a total volume of 50 ml . Isotonic saline (0.9%) are given slow intravenous (I.v) infusion over 15 minutes before induction of general anesthesia
Group 1: received 1.5 ug/kg of clonidine in the infusion regimen
Group 2: received 30 mg/kg of Magnesium sulfate in the infusion
Group 3: received saline only(placebo group) infusion of 50 ml. saline
Intervention code [1] 293389 0
Treatment: Drugs
Comparator / control treatment
Clonidine group is being compared to magnesium sulfate group and placebo group in LC.
Control group
Placebo

Outcomes
Primary outcome [1] 296793 0
Hemodynamic stability(heart rate and mean arterial pressure) using ECG and sphygmomanometer respectively .
Timepoint [1] 296793 0
Baseline(before induction of general anesthesia), 3 minutes after endotracheal intubation, before pneumperitoneum, 15 minutes after pneumperitoneum, 30 minutes after pneumoperitoneum, 5 minutes after ex sufflation , 5 minutes after extubation and 2 hours postoperatively.
Primary outcome [2] 297309 0
Level of cortisol and adrenocorticotrophic hormone(ACTH).
(This is a composite primary outcome) using serum assay.
Timepoint [2] 297309 0
Baseline( 30 minutes before transferring the patient to operative room), 3 minutes after endotracheal intubation,15 minutes after pneumoperitoneum, 5 minutes after exsuflation,2 hours after extubation and first postoperative day.
Secondary outcome [1] 319372 0
Postoperative analgesia
Timepoint [1] 319372 0
Pain is assessed using visual analogue score(VAS) at 2,4,6 ,8,10 and 12 hours postoperatively which is recorded on patient clinical charts by attending nurse.
Secondary outcome [2] 319374 0
Patient sedation.
Timepoint [2] 319374 0
Using Ramsay sedation score at pre-induction and 15 minutes after reaching PACU.

Eligibility
Key inclusion criteria
American society of A nesthesiologists( ASA) I and II, patients with gallbladder diseases subjected for elective laparoscopic cholecystectomy( LC) .
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with cardiovascular,respiratory,renal, hepatic or neurological diseases, diabetes mellitus, pregnancy or breast feeding females, morbidly obese patients, endocrine disorders,prolonged procedures ( more than 120 minutes), patients on anti hypertensives, antipsychotics, analgesics or sedative medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Continuous data will be reported by mean +/- S.D. While categorical data by frequency and percentage. Continuous data will be compared between the three groups via analysis of variance(ANOVA) or kruskal-wallis test, depending on the normal distribution of data, determined by kolmgorov-Smirnov test. Categorical data will be compared between the three groups using chi- square test or fisher's exact test..Repeated measure ANOVA will be used to investigate the changes of the studied variables. P.value< 0.05 will be considered as statistically significant. Based on a pilot study on 10 patients subjected for laparoscopic cholecystectomy, it was calculated that 27 and 5 patients per group were required to detect a significant 20% inter group differences in mean arterial pressure and plasma cortisol level respectively. To compensate for possible droupouts , 35 patients per group were included.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7548 0
Egypt
State/province [1] 7548 0
Qena

Funding & Sponsors
Funding source category [1] 292755 0
University
Name [1] 292755 0
South valley university
Address [1] 292755 0
South valley university- Qena-postal code 85823
Country [1] 292755 0
Egypt
Primary sponsor type
University
Name
South valley university
Address
South valley university-Qena- postal code 85823
Country
Egypt
Secondary sponsor category [1] 291486 0
None
Name [1] 291486 0
Nil
Address [1] 291486 0
Nil
Country [1] 291486 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294241 0
Qena faculty of medicine ethics committee
Ethics committee address [1] 294241 0
Qena-south valley university-postal code 85823
Ethics committee country [1] 294241 0
Egypt
Date submitted for ethics approval [1] 294241 0
03/06/2014
Approval date [1] 294241 0
07/06/2014
Ethics approval number [1] 294241 0

Summary
Brief summary
We will compare preoperative administration of I.V. clonidine and magnesium sulphate in laparoscopic cholecystectomy on stress hormones( cortisol and ACTH levels) , hemdynamic stability and post operative analgesia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48550 0
Dr Hatem Saber Mohamed
Address 48550 0
Qena faculty of medicine- south valley university- postal code 85823-Qena
Country 48550 0
Egypt
Phone 48550 0
+201005257062
Fax 48550 0
Email 48550 0
dr.hatem_saber@hotmail.com
Contact person for public queries
Name 48551 0
Dr Hatem saber mohamed
Address 48551 0
Qena faculty of medicine-south valley university- postal code 85823-Qena
Country 48551 0
Egypt
Phone 48551 0
+201005257062
Fax 48551 0
Email 48551 0
dr.hatem_saber@hotmail.com
Contact person for scientific queries
Name 48552 0
Dr Hatem saber mohamed
Address 48552 0
Qena faculty of medicine-south valley university- postal code 85823-Qena
Country 48552 0
Egypt
Phone 48552 0
+201005257062
Fax 48552 0
Email 48552 0
dr.hatem_saber@hotmail.com

No information has been provided regarding IPD availability
Summary results
No Results