Spinal anesthesia at low and moderately high altitudes: A comparison of anesthetic parameters and hemodynamic changes

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000749606
• Date of registration: 16/07/2014
• Prospective Registration: No
• Primary sponsor: Dr. Mehmet AKSOY
• 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.
• Date of first enrolment: 01/01/2014
• Target sample size: 140
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000749606.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Dr Ilker INCE

• Name: Dr Mehmet AKSOY

Key inclusion & exclusion criteria

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.
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

Age minimum: 25 Years
Age maximum: 40 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Anaesthesiology - Other anaesthesiology

Spinal anesthesia at low and moderately high altitudes;
Spinal anesthesia at low and moderately high altitudes

Intervention(s)

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 m

Primary Outcome(s)

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). [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(s)

anaesthetic complications such as PDPH (increased pain intensity upon standing up from a supine position). [during surgery and postoperative period for up to 24 hours.]

motor block duration [the time from local anaesthetic injection to complete motor function recovery.Complete motor block was defined as a Bromage score of 3. ]

duration of the block procedure [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. ]

duration of surgery [the time from the start of the surgical incision to the completion of surgery]

Highest sensory block level was assessed using Modified Bromage scale. [during surgery (the values in 5,10,20,30,90 th minutes). ]

sensory block time [from local anesthetic injection to the recovery of S2 dermatom]

Secondary ID(s)

None

Source(s) of Monetary Support

Dr.Mehmet AKSOY

Ethics review

Status: Approved
Approval date:
Contact:

Ataturk University Medical Faculty Ethical Committee