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Trial registered on ANZCTR


Registration number
ACTRN12614000749606
Ethics application status
Approved
Date submitted
4/07/2014
Date registered
16/07/2014
Date last updated
16/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Spinal anesthesia at low and moderately high altitudes: A comparison of anesthetic parameters and hemodynamic changes
Scientific title
A comparison of anesthetic parameters and hemodynamic changes in Males undergoing lower extremity surgery with spinal anesthesia at low and moderately high altitudes.
Secondary ID [1] 284922 0
None
Universal Trial Number (UTN)
U1111-1158-8640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal anesthesia at low and moderately high altitudes 292394 0
Condition category
Condition code
Anaesthesiology 292712 292712 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 140 consecutive male subjects who were admitted to 2 study institutions at Ataturk University, Medical Faculty, Erzurum, Turkey (1890 metres above sea level) and Sakarya University, Medical Faculty, Sakarya, Turkey (31 metres above sea level) between January 1, 2014 and June 30, 2014 and who were scheduled elective lower extremity surgery with spinal anesthesia were enrolled in this study.All participants were permanently resident at moderately high altitude, as well as sea level. Written informed consent was obtained from all participating patients. Demographic characteristics (age, weight and height) and indications for surgery of the patients were recorded. Before transfer to the operating room, all patients received ringer’s lactate solution intravenously at 1 to 2 ml/kg/hour via 18-gauge cannula in a forearm peripheral vein. Standard monitoring included non-invasive arterial pressure, electrocardiography and pulse oximetry was established for all patients in the operating room. Before the procedure of anesthesia, each patient was premedicated with intravenous (iv) fentanyl (0.1 µg/kg) and midazolam (2 mg). After skin infiltration with 2% lidocain, 26-gauge Quincke's needle was inserted through the L2-3/ L3-4 intervertebral space of sitting position patient. Once free flow of cerebrospinal fluid was obtained, hyperbaric bupivacaine 0.5%, 9mg (1.8mL) was injected intrathecally. Then, the patient was enrolled in the supine position. Sensory block level was tested using pinprick tests and motor block level was evaluated with Modified Bromage scale (scale 0 = full flexion of foot, knee and hip, ie, no motor block; scale 1 = full flexion of foot and knee, unable to hip flexion; scale 2 = full flexion of foot, unable to knee and hip flexion; scale 3 = total motor block; unable to foot, knee, and hip flexion). When the sensory block reached the T12 dermatome, surgery was initiated. If no signs of analgesia were observed within the first 10 min after intrathecal injection, technique was considered as fail and general anesthesia was administered for these patients. Oxygen was delivered with a face mask during surgery; iv midazolam (1 mg) for complaint of discomfort, iv propofol (10 mg/kg) for sedation and fentanyl (0.1 µg/kg) for pain were administered to each patient if necessary. The quality of the anesthesia was evaluated according to total amount of supplementary sedatives and analgesics during surgery. During the operation, patients' mean arterial blood pressure (MABP), heart rate (HR) and oxygen saturation were monitored and recorded every 5 minutes. Ephedrine (iv, 2.5 mg) was administered in case of hypotension (a 30% decrease in systolic blood pressure compared with preoperative values) and atropine (iv, 0.5 mg) was applied when bradycardia (the heart rate < 45 beats/minute) was observed. Same anesthesia protocol was applied for patients living at moderately high altitude and sea level. The application time of spinal anesthesia, duration of the block procedure (the time from the start of the anesthetic procedure to the development of full motor block), duration of surgery (the time from the start of the surgical incision to the completion of surgery), highest sensory block level, sensory block time (from local anesthetic injection to the recovery of S2) dermatom, motor block duration (the time from local anaesthetic injection to complete motor function recovery), anesthetic complications and total amount of required analgesics and sedatives during surgical procedure were recorded. After surgery, patients were transferred to the orthopaedic ward. The presence of postdural puncture headache (PDPH, increased pain intensity upon standing up from a supine position) was questioned in patients postoperatively. Crystalloid infusions (500 ml, 8-hour intervals) and a nonsteroidal anti-inflammatory drug applied to the patients diagnosed PDPH. If this therapeutic modality was not successful, an epidural blood patch with 10 mL of autologous blood was applied to the patient following the patient’s permission.
Intervention code [1] 289744 0
Treatment: Drugs
Intervention code [2] 289745 0
Treatment: Other
Comparator / control treatment
Comparator group: Moderately high altitude group (1890 metres above sea level)
Control group
Active

Outcomes
Primary outcome [1] 292552 0
To detect the differences, if any, between moderately highlanders and lowlanders in terms of hemodynamic parameters under neuroxial anesthesia via standard monitorization (Datex-Ohmeda, Helsinki, Finland).
Timepoint [1] 292552 0
During the operation, patients' mean arterial blood pressure (MABP), heart rate (HR) and oxygen saturation were recorded every 5 minutes using a standard monitorization (Datex-Ohmeda, Helsinki, Finland).
Secondary outcome [1] 309207 0
duration of the block procedure
Timepoint [1] 309207 0
the time from the start of the anesthetic procedure to the development of full motor block. Complete motor block was defined as a Bromage score of 3.
Secondary outcome [2] 309208 0
duration of surgery
Timepoint [2] 309208 0
the time from the start of the surgical incision to the completion of surgery
Secondary outcome [3] 309209 0
Highest sensory block level was assessed using Modified Bromage scale.
Timepoint [3] 309209 0
during surgery (the values in 5,10,20,30,90 th minutes).
Secondary outcome [4] 309210 0
sensory block time
Timepoint [4] 309210 0
from local anesthetic injection to the recovery of S2 dermatom
Secondary outcome [5] 309211 0
motor block duration
Timepoint [5] 309211 0
the time from local anaesthetic injection to complete motor function recovery.Complete motor block was defined as a Bromage score of 3.
Secondary outcome [6] 309212 0
anaesthetic complications such as PDPH (increased pain intensity upon standing up from a supine position).
Timepoint [6] 309212 0
during surgery and postoperative period for up to 24 hours.

Eligibility
Key inclusion criteria
Male patients with age between 25-40 years, a body mass index between 20-25 kg/m2, ASA (the classification of the American Society of Anesthesiologists) physical status I or II who were scheduled elective lower extremity surgery with spinal anesthesia were included.
Minimum age
25 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Smokers, alcohol consumers, patients with psychiatric or neurological disorders, chronic diseases such as diabetes, a body mass index over 25, ASA physical status III or IV and contraindications to spinal anesthesia such as coagulaton disorder and infection at the puncture site were excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A power analysis for this study was calculated based on the work of Puri et al. using Russ Lenth’s Power and sample size calculation application, 30 patients in each group were needed to detect the difference with a power of 90% at 5% significance level. Data were analysed using SPSS software 12.0 (SPSS Inc., Chicago, IL, USA) and calculated as mean ± standard deviation, P < 0.05 was considered significant. The findings obtained in two different altitudes were compared using appropriate statistical tests. The Kolmogorov-Smirnov test was used to assess the normal distribution of data. If data was not normally distributed, comparisons were determined using Mann-Whitney U-test. Comparisons were determined using the Independent T test when data was normally distributed and Fisher’s exact test was used to compare the percentage values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2014
Actual
1/01/2014
Date of last participant enrolment
Anticipated
30/06/2014
Actual
30/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 6194 0
Turkey
State/province [1] 6194 0
Erzurum

Funding & Sponsors
Funding source category [1] 289546 0
Self funded/Unfunded
Name [1] 289546 0
Dr.Mehmet AKSOY
Country [1] 289546 0
Turkey
Primary sponsor type
Individual
Name
Dr. Mehmet AKSOY
Address
Dr. Mehmet AKSOY
Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240
Country
Turkey
Secondary sponsor category [1] 288231 0
None
Name [1] 288231 0
Address [1] 288231 0
Country [1] 288231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291286 0
Ataturk University Medical Faculty Ethical Committee
Ethics committee address [1] 291286 0
Ethics committee country [1] 291286 0
Turkey
Date submitted for ethics approval [1] 291286 0
20/12/2013
Approval date [1] 291286 0
26/12/2013
Ethics approval number [1] 291286 0
12

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

Contacts
Principal investigator
Name 49694 0
Dr Mehmet AKSOY
Address 49694 0
Department of Anaesthesiology and Reanimation, Faculty of Medicine, Ataturk University, Erzurum, Turkey Postal code: 25240
Country 49694 0
Turkey
Phone 49694 0
+9 0442 3172295
Fax 49694 0
+9 0442 3172294
Email 49694 0
drmaksoy@hotmail.com
Contact person for public queries
Name 49695 0
Mehmet AKSOY
Address 49695 0
Department of Anaesthesiology and Reanimation, Faculty of Medicine, Ataturk University, Erzurum, Turkey Postal code: 25240
Country 49695 0
Turkey
Phone 49695 0
+9 0442 3172295
Fax 49695 0
+9 0442 3172294
Email 49695 0
drmaksoy@hotmail.com
Contact person for scientific queries
Name 49696 0
Ilker INCE
Address 49696 0
Department of Anaesthesiology and Reanimation, Faculty of Medicine, Ataturk University, Erzurum, Turkey Postal code: 25240
Country 49696 0
Turkey
Phone 49696 0
+9 0442 3172295
Fax 49696 0
+9 0442 3172294
Email 49696 0
ilkerince1983@yahoo.com

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
SourceTitleYear of PublicationDOI
EmbaseSpinal anaesthesia at low and moderately high altitudes: A comparison of anaesthetic parameters and hemodynamic changes.2015https://dx.doi.org/10.1186/s12871-015-0104-y
N.B. These documents automatically identified may not have been verified by the study sponsor.