ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000389606

Ethics application status

Approved

Date submitted

17/03/2014

Date registered

10/04/2014

Date last updated

23/04/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Intravenous Dexmedetomidine Infusion In Adult Patients Undergoing Open Nephrolithotomy

Scientific title

Intravenous Dexmedetomidine Infusion In Adult Patients Undergoing Open Nephrolithotomy: Effects On Intraoperative Hemodynamics And Blood loss.

Clinical research study

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1154-5834

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Intraoperative Hemodynamics

Intraoperative Blood loss.

Nephrolithotomy

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients will randomly allocated using a closed envelop technique into two groups (n= 25).

Group D: will receive a bolus dose of dexmedetomidine (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA) 1ug/kg over 10 min before induction of anesthesia then dexmedetomidine iv infusion of 0.1 ug-0.5ug/kg/h infused continuously throughout the operation. guided by hemodynamics

Group P: will receive a bolus dose of 10 ml ringer solution before induction of anesthesia, and continuous intraoperative infusion 10 ml /h ringer solution

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Prevention

Comparator / control treatment

Group P: will receive a bolus dose of 10 ml ringer solution before induction of anesthesia, and continuous intraoperative infusion

Control group

Placebo

Outcomes

Primary outcome [1]

Heart rate

Timepoint [1]

Monitored continuously intraoperative with ECG

Secondary outcome [1]

Volume of blood loss:in the suction drain and swabs

Timepoint [1]

measured intraoperative

Secondary outcome [2]

Number of packed red blood cells transfused

Timepoint [2]

measured intraoperative

Secondary outcome [3]

Laboratory Hb

Timepoint [3]

Pre, intra and immediate post-operative

Secondary outcome [4]

Laboratory haematocrite concentration

Timepoint [4]

Pre, intra and immediate post-operative

Eligibility

Key inclusion criteria

ASA I and II males and females patients aged 20-60 years old, planned for elective open nephrolithotomy under general anesthesia

Minimum age

20 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

ASA more than II , had a known cardiac arrhythmias ,significant liver disease defined as (serum alanine aminotransferase and serum aspartate aminotransferase >2.5 times normal),significant renal disease defined as (serum creatinine >1.5 mg/dl or creatinine clearance <40 ml/min),pregnant patient, significant coagulopathy defined as (INR >1.5),use of antiplatlets or anticoagulants ,anemic patients with Hb% less than 10 gm/dl

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)

The study drugs will be prepared by a senior anesthetia resident unaware of the study protocol
Patients will randomly allocated using a closed envelop technique into two groups

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The study drugs will be prepared by a senior anesthetia resident unaware of the study protocol
Patients will randomly allocated using a closed envelop technique into two groups
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Statistical analysis:
After a pilot study in ten patients, the mean intraoperative blood loss (SD) was 621 (143) and 782 (338) in the dexmedetomidine group and the placebo group, respectively. Therefore, the sample size was calculated using the program of biostatistics version 3.01 twenty five per group was needed to show a difference of intraoperative blood loss 161 ml (SD 195 ml) between groups with the power was set at 80% and the a-error level was fixed at 0.05.
Data are presented as mean ± standard deviation (SD) or median (range) or numbers as appropriate , Numerical data were analyzed by using Student’s unpaired ttest.Nonparametric data were analyzed by using the Mann
Whitney U-test. A value of P < 0.05 was considered statistically significant.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/04/2014

Actual

1/04/2014

Date of last participant enrolment

Anticipated

30/09/2014

Actual

1/09/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

benisuef

Funding & Sponsors

Funding source category [1]

University

Name [1]

egypt ,benisuef governerate
benisuef university
mokbel

Address [1]

egypt,

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511

Country [1]

Egypt

Primary sponsor type

Hospital

Name

benisuef university hospital

Address

egypt,

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511

Country

Egypt

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

research ethical comittee

Ethics committee address [1]

benisuef university faculty of medecine
(FMBSU) 
egypt,



 -,mokbel,mohamad anwar hassan street, 62511

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

17/03/2014

Approval date [1]

25/03/2014

Ethics approval number [1]

Summary

Brief summary

Patients and Methods:
After approval of the ethical committee in Beni  suef University (FMBUS REC,Egypt) the study was  registered at ANZCTR clinical trial registry  ,(registration number ACTRN12614000389606),a written informed consents were obtained from 50 patients ASA I and II   males  and  females aged 20-60 years old, scheduled  for  elective open  nephrolithotomy under general anesthesia from March 2014 to September 2014.   
Patients were excluded if they were ASA more than  II ,  had a known cardiac arrhythmias, significant liver disease defined as (serum alanine aminotransferase and serum aspartate aminotransferase >2.5 times normal),significant renal disease defined as (serum creatinine>1.5 mg/dl or creatinine clearance <40 ml/min),pregnant patient, significant coagulopathy defined as (INR >1.5),use of antiplatlets or anticoagulants, anemic patients with Hb% less than 10 gm/dl.
 In the operating room, two  intravenous cannula was inserted , monitors were connected   including     Electrocardiogram,  pulse oximetry, non-invasive arterial blood pressure at 5 minutes intervals and BIS monitor strip (BIS Sensor; Aspect Medical Systems, USA, Toll free 1-888-BIS Index)
The study drugs were prepared by a senior anesthesia resident unaware of the  study protocol
Patients were randomly allocated using a closed envelop technique into two groups (n= 25 each).
Group D: received  in a separate cannula a bolus dose of dexmedetomidine (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA) 1 micogram/kg over 10 min before induction of anesthesia then iv infusion of 0.1 -0.5 micogram/kg/h guided by the hemodynamics.
Group P: received a bolus dose of 10 ml ringer lactate solution before induction of anesthesia then continuous infusion till the end of the operation. 
Preoxgenation for 3- 5 minute with 100% oxygen by facemask, then induction of anesthesia in all patients was  with the use of    i.v. fentanyl 2 micogram / kg, propofol 2 mg/ kg, , atracurium (0.5mg/kg) and  ventilated manually with sevoflorane  2 volume % ,oxygen 100% via a face mask  then  oral cuffed endotracheal tube was inserted  when the BIS value reached (40-60) which indicate optimal  hypnotic  state , anesthesia was maintained with oxygen 100%, sevoflurane (according to the depth of  anesthesia  guided by BIS to be between 40%-60%),muscle relaxation was maintained by additional doses of  atracurium, guided by peripheral nerve stimulator ( Life-Tech EZstimII), mechanical ventilation with maintenance of end tidal carbon dioxide 36-40mmHg,all patients received 15mg/kg Pefalgan and 2 micogram /kg fentanyl IV. A wide bore IV cannula was  also inserted. Hypotension defines as systolic blood pressure less than 90 mmHg was treated by decreasing the dexmedetomidine concentration and or sevoflorane concentration and ephedrine in 3 mg IV  increments of needed, bradycardia is defined  as heart rate less than 60 beat per minute  and  was managed by decreasing the dexmedetomidine concentration in D group   or atropine 0.5mg IV if needed.

At the end of surgery, 0.25% bupivacaine
was injected by the surgeon at the surgical wound, neuromuscular blockade was  reversed with IV neostigmine 0.04mg/kg  and atropine 0.02 mg/kg, the trachea was extubated when the patient respond to commands, all patients were transferred to PACU,  where they received oxygen via face mask 3-4 L/min and were  monitored.
The following parameters were evaluated and recorded by senior anesthesia resident unaware of the  study protocol:
1.	Patients’s characteristics : age, sex, height, weight, ASA physical status and duration of  surgery.

2.	Heart rate, systolic and diastolic arterial blood pressure, arterial oxygen saturation (SpO2): before induction, after induction of anesthesia, then every 15 minutes  intraoperative.



3.	Volume of blood loss (ml) :in the surgical swabs and suction bottle 

4.	Laboratory Hb and hematocrit concentration :(Pre, intra and immediate post-operative)
5.	Number of  units PRBCs transfused 
6.	Urine output (ml)

Trial website

Trial related presentations / publications

paper sent for evalution

Public notes

Attachments [1]

/AnzctrAttachments/365983-protocol 2.docx

Attachments [2]

/AnzctrAttachments/365983-ethical aproval.docx

Contacts

Principal investigator

Name

Dr doaa rashwan

Address

doaa rashwan egypt
benisuef governerate mokbel

egypt,

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511

Country

Egypt

Phone

+2020822318605

Fax

[email protected]

Contact person for public queries

Name

doaa rashwan

Address

doaa rashwan egypt benisuef governerate mokbel
egypt,

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511

Country

Egypt

Phone

+20822318605

Fax

[email protected]

Contact person for scientific queries

Name

doaa rashwan

Address

doaa rashwan egypt
benisuef governerate

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511

Country

Egypt

Phone

+20822318605

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Intravenous dexmedetomidine infusion in adult patients undergoing open nephrolithotomy: Effects on intraoperative hemodynamics and blood loss; A random ized controlled trial.	2015	https://dx.doi.org/10.1016/j.egja.2015.03.007

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically