The effect of spontaneous ventilation with mask on tissue oxygenation in parturients undergoing cesarean section under spinal anesthesia;

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000625471
• Date of registration: 13/05/2016
• Prospective Registration: No
• Primary sponsor: Harran University School of Medicine, Research and Training Hospital
• Public title: The effect of spontaneous ventilation with mask on tissue oxygenation in parturients undergoing cesarean section under spinal anesthesia;
• Scientific title: The effect of spontaneous ventilation with venturi mask on tissue oxygenation in parturients undergoing cesarean section under spinal anesthesia; a randomized controlled study
• Date of first enrolment: 01/01/2016
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000625471.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Turkey

Contacts

• Name: A/Prof Mahmut Alp Karahan

• Name: A/Prof mahmut alp karahan

Key inclusion & exclusion criteria

Inclusion criteria: ASA physical status I–II term parturients
undergoing elective CS under spinal anesthesia
Exclusion criteria: ASA status; > II
Coexisting disease; metabolic, endocrine, hepatic, cardiac or renal diseases, malignancies, preeclampsia; hypertension;
Concurrent medication used; or recent use (within 48h) of any drug with anti-oxidant properties such as nebivolol, carvedilol, vitamins E and C, or acetylcysteine

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Other anaesthesiology

otherwise healthy parturients planned for cesarean section;
otherwise healthy parturients planned for cesarean section

Intervention(s)

All patients will randomized with the closed envelope method.

All patients will be monitored and the basal vital functions (HR, SpO2, NIBP and StO2) will be recorded with admission into the OR.

All patients will placed into a sitting position and spinal anesthesia will be performed with a median approach, at a level of L3-L4, with a 25 G Quincke type spinal needle and 2.5 ml hyperbaric bupivacaine.

After succesful administration of anesthesia, all patients will be placed into supine position, monitored and administered oxygene via a venturi mask after administration of spinal anesthesia until the completion of surgery in different inspirated fractions (31%, 40% and 60%) and all vital functions will be recorded (HR, SpO2, NIBP and StO2) after spinal anesthesia (in minute 1, 3 and 5), with the beginning of surgery (in minute 5, 10, 15, 20, 25, 30 and 40), after the end of surgery (in minute 5, 10, 15, 30 and 60) and in the 24th hour postoperatively

Beside this, hemoglobin levels will be evaluated preoperatively, during surgery and postoperatively in the 30th and 60th minute, by a noninvasive continuous monitoring device.

Spinal block levels, duration of surgery, APGAR scores, vasopressor consumption will be recorded.

Primary Outcome(s)

The impact of different inspiratory fractions of oxygene on tissue oxygenation assessed by the InSpectra tissue spectrometer (Hutchinson technology, Hutchinson, MN, USA) is the primary goal of the study.[StO2 will be assessed at admission to OR, after spinal anesthesia (in minute 1, 3 and 5), with the beginning of surgery (in minute 5, 10, 15, 20, 25, 30 and 40), after the end of surgery (in minute 5, 10, 15, 30 and 60) and in the 24th hour postoperatively.]

Secondary Outcome(s)

The impact of different inspiratory fractions of oxygen on pediatric APGAR scores which will be evaluated in the OR after delivery by a pediatrist.[APGAR scores in 1 minute and 5 minutes after delivery]

Secondary ID(s)

none

Source(s) of Monetary Support

Harran University

Ethics review

Status: Approved
Approval date:
Contact:

Harran university medical faculty ethics committe