Investigation Of The Effects Of Unilateral And Bilateral Spinal Anesthesia On Cerebral Blood Flow

NCT06871449 | Completed

• 1 other identifier: Mehtap Balcı
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia is a widely used method in anesthesia practice. Unilateral spinal block refers to a neuroaxial technique that induces motor and sensory blockade on the surgical side. While spinal anesthesia offers numerous advantages, it is associated with complications such as hypotension, headache, transient neurological symptoms, and meningitis. Among these, hypotension is the most common. To mitigate hemodynamic issues, intravenous fluid preloading and vasopressor use are standard practices in many centers. This study aimed to compare regional cerebral oxygenation (rSO₂) values in patients undergoing unilateral and bilateral spinal blocks to identify the least complicated and most effective method. Minimizing complications can facilitate early mobilization, reduce hospital stays, and lower infection risks. The study included 60 male patients (aged 18-65 years) scheduled for unilateral inguinal hernia surgery at Kayseri City Hospital. Inclusion criteria were the absence of coagulation disorders, infections, or systemic diseases, hemoglobin levels \>10 g/dL, and BMI \<30. Patients were randomized into two groups: Group I: Unilateral spinal anesthesia with 15 mg hyperbaric bupivacaine. Patients were placed in a lateral position on the surgical side for 5 minutes, then moved to the supine position. Group II: Bilateral spinal anesthesia with 15 mg hyperbaric bupivacaine. Patients were placed in the supine position for 5 minutes. Sensory block levels were assessed using the pin-prick test, and motor blocks were evaluated with the Bromage scale. Surgery commenced when the sensory block reached the T10 level. Patient data, including age, BMI, hemoglobin, baseline systolic/diastolic blood pressure (SBP/DBP), mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO₂), and rSO₂, were recorded before and after spinal anesthesia. SBP, DBP, MAP, HR, SpO₂, and rSO₂ values were monitored at 5-minute intervals for 30 minutes.

Conditions

Adverse Effect; Cerebral Perfusion

Keywords

Spinal Block, Near-Infrared Spectroscopy ,Cerebral Oxygenation

Outcome Measures

Primary Outcomes (1)

• Regional Cerebral Oxygenation

  rSO₂ values were monitored

  5-minute intervals for 30 minutes.

Study Arms (2)

unilateral Spinal Block(GroupI)

Group I: After appropriate area cleaning, under sterile conditions, the spinal space was accessed through the L4-L5 interspace, and 15 mg of hyperbaric bupivacaine (3 cc, Buvasin 0.5% Spinal Heavy) was administered following the observation of free, clear cerebrospinal fluid (CSF) flow. The patient was then kept in the lateral position on the surgical side for 5 minutes before being moved to the supine position.

Bilateral Spinal Block (Group II)

Group II: After appropriate area cleaning, under sterile conditions, the spinal space was accessed through the L4-L5 interspace, and 15 mg of hyperbaric bupivacaine (3 cc, Buvasin 0.5% Spinal Heavy) was administered following the observation of free, clear cerebrospinal fluid (CSF) flow. The patient was then kept in the supine position for 5 minutes.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 60 male volunteer patients, aged 18-65 years, scheduled for unilateral inguinal hernia surgery in the operating room of Kayseri City Hospital, were included.

You may qualify if:

• No coagulation disorders or prolonged bleeding times
• No infections at the injection site or systemic infections
• Ability to cooperate
• No history of opioid use or local anesthetic allergy
• No cardiovascular, respiratory, or metabolic diseases
• Hemoglobin levels \>10 g/dL
• BMI \<30

You may not qualify if:

• Coagulation disorders present
• Infections at the injection site or systemic infections
• Inability to cooperate
• History of opioid use or local anesthetic allergy
• Cardiovascular, respiratory, or metabolic diseases present
• Hemoglobin levels \<10 g/dL
• BMI \>30

Sponsors & Collaborators

• Nuh Naci Yazgan University: lead
• Kayseri City Hospital: collaborator

Study Sites (1)

Nuh Naci Yazgan Üniversity Faculty of Dentistry

Kayseri, Kocasinan, 38000, Turkey (Türkiye)

Location

Related Publications (8)

• Kusku A, Demir G, Cukurova Z, Eren G, Hergunsel O. Monitorization of the effects of spinal anaesthesia on cerebral oxygen saturation in elder patients using near-infrared spectroscopy. Braz J Anesthesiol. 2014 Jul-Aug;64(4):241-6. doi: 10.1016/j.bjane.2013.06.012. Epub 2013 Oct 18.

  PMID: 24998107 RESULT

• Nishikawa K, Hagiwara R, Nakamura K, Ishizeki J, Kubo K, Saito S, Goto F. The effects of the extent of spinal block on the BIS score and regional cerebral oxygen saturation in elderly patients: A prospective, randomized, and double-blinded study. J Clin Monit Comput. 2007 Apr;21(2):109-14. doi: 10.1007/s10877-006-9063-7. Epub 2007 Jan 10.

  PMID: 17216322 RESULT

• Minville V, Asehnoune K, Salau S, Bourdet B, Tissot B, Lubrano V, Fourcade O. The effects of spinal anesthesia on cerebral blood flow in the very elderly. Anesth Analg. 2009 Apr;108(4):1291-4. doi: 10.1213/ane.0b013e31819b073b.

  PMID: 19299802 RESULT

• Hoppenstein D, Zohar E, Ramaty E, Shabat S, Fredman B. The effects of general vs spinal anesthesia on frontal cerebral oxygen saturation in geriatric patients undergoing emergency surgical fixation of the neck of femur. J Clin Anesth. 2005 Sep;17(6):431-8. doi: 10.1016/j.jclinane.2004.09.013.

  PMID: 16171663 RESULT

• Hino A, Ueda S, Mizukawa N, Imahori Y, Tenjin H. Effect of hemodilution on cerebral hemodynamics and oxygen metabolism. Stroke. 1992 Mar;23(3):423-6. doi: 10.1161/01.str.23.3.423.

  PMID: 1542907 RESULT

• Sun S, Liu NH, Huang SQ. Role of cerebral oxygenation for prediction of hypotension after spinal anesthesia for caesarean section. J Clin Monit Comput. 2016 Aug;30(4):417-21. doi: 10.1007/s10877-015-9733-4. Epub 2015 Jul 18.

  PMID: 26186992 RESULT

• Aydin G, Sayan CD. Is body mass index a risk factor for low cerebral oxygenation during spinal anesthesia in women undergoing cesarean section? A preliminary study. Turk J Med Sci. 2019 Jun 18;49(3):854-861. doi: 10.3906/sag-1810-208.

  PMID: 31190520 RESULT

• Hirose N, Kondo Y, Maeda T, Suzuki T, Yoshino A. Relationship between regional cerebral blood volume and oxygenation and blood pressure during spinal anesthesia in women undergoing cesarean section. J Anesth. 2016 Aug;30(4):603-9. doi: 10.1007/s00540-016-2165-6. Epub 2016 Mar 24.

  PMID: 27011334 RESULT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: March 12, 2025
• Study Start: March 27, 2022
• Primary Completion: November 29, 2022
• Study Completion: March 27, 2023
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

TU (1)