Brain Aneurysm Clinical Trial
Official title:
Efficacy of Superior Cervical Ganglion (SCG) Block on the Incidence and Severity of Vasospasm After Middle Cerebral Artery (MCA)Aneurysmal Surgery Using Transcranial Doppler(TCD). A Randomized Controlled Trial.
Verified date | July 2022 |
Source | Kasr El Aini Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to assess blood flow velocity in middle cerebral artery measured by transcranial doppler to determine the efficacy of SCG block in decreasing incidence or severity of vasospasm after MCA aneurysm surgery.
Status | Completed |
Enrollment | 36 |
Est. completion date | July 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients aged from 18 to 70 years. - Genders eligible for study: both sexes. - ASA I-II. - GCS (13-15) Exclusion Criteria: - Patient refusal - Contraindications to regional anesthesia (Bleeding disorders, Use of any anti-coagulants, local infection). - Known allergy to local anesthetics. - ASA III-IV. - Patients aged less than 18 or more than 70. |
Country | Name | City | State |
---|---|---|---|
Egypt | kasr Al Ainy hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Fatma Ibrahim El Sayed Salman |
Egypt,
Koning HM, Dyrbye BA, van Hemert FJ. Percutaneous Radiofrequency Lesion of the Superior Cervical Sympathetic Ganglion in Patients with Tinnitus. Pain Pract. 2016 Nov;16(8):994-1000. doi: 10.1111/papr.12348. Epub 2015 Aug 27. — View Citation
Kurth CD, Wagerle LC, Delivoria-Papadopoulos M. Sympathetic regulation of cerebral blood flow during seizures in newborn lambs. Am J Physiol. 1988 Sep;255(3 Pt 2):H563-8. — View Citation
Rumalla K, Smith KA, Arnold PM, Mittal MK. Subarachnoid Hemorrhage and Readmissions: National Rates, Causes, Risk Factors, and Outcomes in 16,001 Hospitalized Patients. World Neurosurg. 2018 Feb;110:e100-e111. doi: 10.1016/j.wneu.2017.10.089. Epub 2017 Oct 26. — View Citation
Sharma AK, Bathala L, Batra A, Mehndiratta MM, Sharma VK. Transcranial Doppler: Techniques and advanced applications: Part 2. Ann Indian Acad Neurol. 2016 Jan-Mar;19(1):102-7. doi: 10.4103/0972-2327.173407. — View Citation
Siegenthaler A, Haug M, Eichenberger U, Suter MR, Moriggl B. Block of the superior cervical ganglion, description of a novel ultrasound-guided technique in human cadavers. Pain Med. 2013 May;14(5):646-9. doi: 10.1111/pme.12061. Epub 2013 Feb 25. — View Citation
Tuor UI. Local distribution of the effects of sympathetic stimulation on cerebral blood flow in the rat. Brain Res. 1990 Oct 8;529(1-2):224-31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline Blood flow velocity in middle cerebral artery measured by transcranial doppler (TCD) | Change in Blood flow velocity in patients with ruptured aneurysmal subarachnoid hemorrhage undergoing MCA aneurysmal surgeries measured by transcranial doppler | The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 & TCD7) | |
Secondary | Incidence or severity of MCA postoperative spasm over 14 days. | TCD MCA vasospasm diagnostic criteria :
Proximal MCA vasospasm can be diagnosed by any of the following: MCA Mean flow velocities of > 200 cm/s, Rapid rise in flow velocities (> 65 cm/s in one day), or Lindegaard ratio (VMCA/VICA >6). |
within 14 days | |
Secondary | Change from baseline heart rate | Heart rate will be measured | Baseline (Before surgery) ,after induction the block and at the end of surgery | |
Secondary | Change from baseline mean arterial blood pressure | Mean arterial blood pressure will be measured | Baseline (Before surgery) ,after induction the block and at the end of surgery | |
Secondary | Change from baseline oxygen saturation (Sao2) | Oxygen saturation (Sao2) will be measured | Baseline (Before surgery) ,after induction the block and at the end of surgery | |
Secondary | Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression). | Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression) will be assisted | within 14 days | |
Secondary | Glasgow coma scale | Glasgow coma scale will be calculated | Baseline (Preopetative), at day 3 and day 7 |
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