Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000837527
Ethics application status
Approved
Date submitted
8/12/2014
Date registered
11/08/2015
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparative evaluation of general anesthesia versus spinal anesthesia combined with paravertebral block for renal surgeries
Scientific title
General anesthesia versus spinal anesthesia combined with paravertebral block for renal surgeries regarding haemodynamic parameters, surgical conditions
Secondary ID [1] 285800 0
no
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia during renal surgeries 293693 0
Condition category
Condition code
Anaesthesiology 293994 293994 0 0
Anaesthetics
Renal and Urogenital 294389 294389 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive ranitidine 150 mg as premedication a night before and on the morning of surgery with a sip of water. In the operation theatre, intravenous (IV) access will be secured with 18G cannula and all patients were pre-loaded with 10 ml/kg of Ringer lactate solution. Standard monitoring include electrocardiogram, pulse oximetry (SpO 2 ), non-invasive blood pressure, urinary output and respiratory rate (RR).

Group I: includes patients for whom paravertebral catheter will be inserted on the proposed side of operation, in sitting posture, under strict aseptic precautions and after infiltration with local anesthetic, 2.5 cm lateral to the tip of spinous process of T10 vertebra, Tuohy needle was advanced perpendicular to the skin in all planes to contact the transverse process of the vertebra, typically at a depth of 2 to 4 cm. After the transverse process was identified, the needle was redirected cephalad and gradually advanced until loss of resistance was felt 1 to 1.5 cm distal to its superior edge.
Through the needle a 18G epidural catheter was placed 3 cm inside T10–T11 paravertebral space. Then, spinal anesthesia was performed with spinal needle 25 gauge at the level of L3-L4 with 2 ml bupivacine 0.5%. Sensory levels were checked with bilateral pin -prick method while motor blockade was assessed with modified Bromage scale (0 = no block, 1 = inability to raise extended leg, 2 = inability to flex the knee and 3 = inability to flex ankle and foot). Paravertebral block was performed with 10 ml bupivacine 0.5%. Equipments for general anesthesia will be ready in case of failure of regional technique.

Intervention code [1] 290774 0
Treatment: Drugs
Comparator / control treatment
Group II: Induction of anesthesia will be achieved with propofol 2 mg/kg, fentanyl 1microgram/kg will be given intravenously. and cis-atracurium 0.15 mg/kg as a muscle relaxant to facilitate endotracheal intubation with appropriate sized endotracheal tube. Maintenance of anesthesia will be achieved with isoflurane (1 MAC), oxygen and cis-atracurium as a muscle relaxant increments and fentanyl 0.5micro gram /kg when will be required. Isoflurane will be tapered before the anticipated end of surgery and stopped during the completion of skin closure. The patients will be extubated after adequate recovery.
Control group
Active

Outcomes
Primary outcome [1] 293776 0
Haemodynamic parameters is a composite primary outcome including; heart rate by ECG and mean arterial blood pressure by Non invasive monitor every 5 minutes for 15 minutes after induction of anesthesia and then every 15 minute till end of surgery.
Timepoint [1] 293776 0
Heart rate and mean arterial blood pressure every 5 minutes for 15 minutes after induction of anesthesia and then every 15 minute till end of surgery.
Primary outcome [2] 293777 0
surgeon's satisfaction by 5 point scale
Timepoint [2] 293777 0
intra-operatively
Secondary outcome [1] 311800 0
Opioid consumption during the follow up period by patient self-report in daily diary
Timepoint [1] 311800 0
during follow up period (one year)
Secondary outcome [2] 311804 0
Side-effects such as nausea and vomiting, headache, respiratory depression, shivering and dry mouth will be noted during intra-operative period in awake patients
Timepoint [2] 311804 0
intraoperatively
Secondary outcome [3] 312700 0
Patient satisfaction t by 10-point scale
Timepoint [3] 312700 0
during surgery for awake patients, the recovery period and first analgesic requirement in the immediate post-operative period in both groups up to 12 hours post-operative

Eligibility
Key inclusion criteria
American Society of Anesthesiologists (ASA) Class-I and II adult patients of either gender in the age group of 18-60 years undergoing renal surgeries (pyelo-lithotomy, uretero-lithotomy, and nephrectomy) will be enrolled in the study. A written informed consent will be obtained from all the patients
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
diabetes mellitus, uncontrolled hypertension, cardiac rhythm disturbances, obesity, severe pulmonary disease, hepatic impairment, deranged coagulation profile, cerebrovascular disorder.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2015
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6514 0
Egypt
State/province [1] 6514 0

Funding & Sponsors
Funding source category [1] 290363 0
Self funded/Unfunded
Name [1] 290363 0
Ahmed A. Eldaba
Country [1] 290363 0
Egypt
Funding source category [2] 290364 0
Self funded/Unfunded
Name [2] 290364 0
Sabry M. Amin
Country [2] 290364 0
Egypt
Primary sponsor type
Individual
Name
Ahmed A. Eldaba
Address
Assistant professor- Department of anesthesia & surgical intensive care
Faculty of medicine- Tanta university
Egypt- El-Geish street - Tanta city- 31527
Country
Egypt
Secondary sponsor category [1] 289087 0
Individual
Name [1] 289087 0
Sabry M. Amin
Address [1] 289087 0
Assistant professor- Department of anesthesia & surgical intensive care
Faculty of medicine- Tanta university
Egypt- El-Geish street - Tanta city- 31527
Country [1] 289087 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292067 0
Faculty of medicine- Tanta university
Ethics committee address [1] 292067 0
Ethics committee country [1] 292067 0
Egypt
Date submitted for ethics approval [1] 292067 0
Approval date [1] 292067 0
01/12/2014
Ethics approval number [1] 292067 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53322 0
A/Prof Ahmed A. Eldaba
Address 53322 0
Assistant professor- Department of anesthesia & surgical intensive care
Faculty of medicine- Tanta university
Egypt- El-Geish street - Tanta city- 31527
Country 53322 0
Egypt
Phone 53322 0
+201223433573
Fax 53322 0
Email 53322 0
[email protected]
Contact person for public queries
Name 53323 0
Sabry M. Amin
Address 53323 0
Assistant professor- Department of anesthesia & surgical intensive care
Faculty of medicine- Tanta university
Egypt- El-Geish street - Tanta city- 31527
Country 53323 0
Egypt
Phone 53323 0
+2012221793439
Fax 53323 0
Email 53323 0
[email protected]
Contact person for scientific queries
Name 53324 0
Sabry M. Amin
Address 53324 0
Assistant professor- Department of anesthesia & surgical intensive care
Faculty of medicine- Tanta university
Egypt- El-Geish street - Tanta city- 31527
Country 53324 0
Egypt
Phone 53324 0
+2012221793439
Fax 53324 0
Email 53324 0
[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
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