Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Title : SEACOAST 1 SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke 1: a Randomized Controlled Phase 2B Clinical Trial
Brief Summary: SEACOAST 1 is a prospective, randomized, blinded endpoint trial comparing collateral vigor and clinical outcomes, with different forms of GA in patients with acute ischemic stroke due to anterior circulation large vessel occlusion (LVO) undergoing mechanical thrombectomy. The study compares GA with normocarbia (GAN) versus GA with mild hypercarbia (GAH), with a primary outcome of collateral robustness at measured at catheter angiography and clinical efficacy as secondary outcome. It is anticipated that the SEACOAST 1 will be followed by a larger, pivotal trial, SEACOAST 2, with primary clinical endpoints, in which the best method of GA identified in SEACOAST 1 is compared with the alternative strategy of anesthesia care (MAC) with minimal or no sedation. The current study focuses uppn SEACOAST 1, which is to be conducted in University of California, Los Angeles Ronald Reagan Medical Center and Santa Monica Medical Center. All acute stroke patients who arrive to one of these two stroke centers and are deemed eligible for thrombectomy will be considered for the proposed study. Physician-investigators will determine study eligibility. Informed consent to participate in the study will be obtained from legally authorized representatives or competent patients. For non-competent patients without on-scene legally authorize representatives, the consent process will utilize enrollment in emergency circumstances with exemption of informed consent (EFIC).


Options:
A: Arm Label: Local anesthesia/conscious sedation; Type: OTHER; Interventions: Procedure: Local anesthesia/concious sedation, Procedure: Spontaneous breath | Arm Label: General anesthesia; Type: OTHER; Interventions: Procedure: General anesthesia, Procedure: Controlled ventilation | Intervention Type: PROCEDURE; Name: General anesthesia; Assigned to Arm(s): General anesthesia | Intervention Type: PROCEDURE; Name: Local anesthesia/concious sedation; Assigned to Arm(s): Local anesthesia/conscious sedation | Intervention Type: PROCEDURE; Name: Spontaneous breath; Assigned to Arm(s): Local anesthesia/conscious sedation | Intervention Type: PROCEDURE; Name: Controlled ventilation; Assigned to Arm(s): General anesthesia
B: Arm Label: GA with mild hypercarbia (GAH); Type: ACTIVE_COMPARATOR; Interventions: Other: Tight control of end-tidal CO2 levels | Arm Label: GA with normocarbia (GAN); Type: ACTIVE_COMPARATOR; Interventions: Other: Tight control of end-tidal CO2 levels | Intervention Type: OTHER; Name: Tight control of end-tidal CO2 levels; Assigned to Arm(s): GA with mild hypercarbia (GAH), GA with normocarbia (GAN)
C: Arm Label: POS group; Type: EXPERIMENTAL; Interventions: Procedure: post-operative sedation | Arm Label: Con group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: routine recovery | Intervention Type: PROCEDURE; Name: post-operative sedation; Assigned to Arm(s): POS group | Intervention Type: PROCEDURE; Name: routine recovery; Assigned to Arm(s): Con group
D: Arm Label: General anaesthesia; Type: EXPERIMENTAL; Interventions: Drug: Sevorane Remifentanil | Arm Label: Sedation; Type: PLACEBO_COMPARATOR; Interventions: Drug: Remifentanil | Intervention Type: DRUG; Name: Sevorane Remifentanil; Assigned to Arm(s): General anaesthesia | Intervention Type: DRUG; Name: Remifentanil; Assigned to Arm(s): Sedation

Answer: B