Clinical trial NCT01438931: Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation
Official title: Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation Under Monitored Sedation Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedation
Keywords: Dexmedetomidine
Sedation
Non-intubation
local anesthesia
Lead sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Maruishi Pharmaceutical
First posted: 2011-09-22
Enrollment: 162
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and the safety of DA-9501 (Dexmedetomidine) in sedation during the surgery or medical procedure without intubation under monitored sedation care.

Detailed description: Phase III, randomized, placebo controlled, double blind, parallel comparative study (Therapeutic confirmatory trial), to evaluate the efficacy and the safety of Dexmedetomidine in non-intubated patients who require sedation during surgery or medical procedure under monitored sedation care.

Eligibility criteria: Inclusion Criteria:

1. Patient has signed and dated the Informed Consent after the study had been fully explained.
2. Patient is male or female, at least 20 years of age when the Informed Consent is obtained.
3. American Society for Anesthesiologists (ASA) I to III Class at the preoperative diagnosis.
4. New York Heart Association (NYHA) classification is I to III (Only patients who need classification of cardiac performance.)
5. Patient who requires sedation during the following elective surgery or procedure which require ≥30mins (expected time) without intubation under monitored sedation care.

   - Orthopedic, Otorhinologic, Oral surgeries, AV fistulas, Plastic, Excision of lesion, Breast biopsy, Catheter ablation, Vascular stents and AV shunt
6. Patient who requires local or regional anesthesia.

Exclusion Criteria:

1. Patient who underwent general anesthesia within 7 days, or who received other study drugs within 30 days from the date of consent.
2. Patient with \<92% SpO2 at the physical examination prior to the study drug administration, or ventilatory failure which requires intubation or Laryngeal Mask.
3. Patient with central nervous system pathology which may lead to increased intracranial pressure, uncontrolled seizures, psychiatric disorder which may be confused with the response to sedation treatment.
4. Patient who require neurosurgical or cerebrovascular catheter procedures or interventions.
5. Patient who require general anesthesia, epidural anesthesia or spinal anesthesia for surgery or procedure.
6. Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.
7. Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used in the study are contraindicated.
8. Patient diagnosed unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
9. Patient whose heart rate less than 50 bpm, systolic blood pressure less than 90 mm Hg by the physical examination prior to the study drug administration.
10. Patient has third degree heart block, unless the patient has a pacemaker.
11. Patient who has experienced an increase in alanine transaminase (ALT) and/or aspartate aminotransferase (AST) more than double the upper normal limit within 2 months of the date of consent, or who has a history of liver insufficiency.
12. Pregnant or lactating woman.
13. In the Investigator's or subinvestigator's opinion, patient has any symptom or factor, which might increase risk to the patient by conducting the study or preclude obtaining satisfactory study data.

Primary outcomes:
measure: Incidence of patients who did not require rescue administration of propofol to achieve and maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 during the study drug administration
timeFrame: Pre-dose, every 5 ± 2 minutes during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Secondary outcomes:
measure: Administration frequency and dosage of propofol required to achieve and maintain OAA/S score ≤4 during the study drug administration
timeFrame: After the start of study drug (20 ± 2 minutes), if the OAA/S score is 5.
measure: Time to first rescue administration of propofol
timeFrame: ≥15 minutes after the start of study drug infusion.
measure: Incidence of patients who did not require rescue administration of fentanyl during the study drug administration
timeFrame: After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.
measure: Administration frequency and dosage of fentanyl required during the study drug administration
timeFrame: After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.
measure: Percentage of time spent OAA/S Score ≤4 during the study drug infusion
timeFrame: Pre-dose, every 5 ± 2 minutes during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
measure: Percentage of time spent OAA/S Score 3 to 4 during the study drug infusion
timeFrame: Pre-dose, every 5 ± 2 minutes during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
measure: Time to attain an Aldrete score ≥9 following discontinuation of the study drug infusion
timeFrame: Every 15 ± 2 minutes until the total score value becomes ≥9.
measure: Visual Analogue Scale (VAS) score evaluation by Investigator or sub-investigator (ease of maintaining sedation level, hemodynamic stability, respiratory stability, subject's cooperativeness)
timeFrame: Within 24 hours after completion of the study drug administration
measure: Score evaluation of satisfaction and anxiety of the subject
timeFrame: Within 24 hours after completion of the study drug administration (as much as possible)
Other outcomes:
Locations:
city: Asahikawa-City
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki Hospital
state: Hyogo
city: Tsukuba
country: Japan
facility: Tsukuba University Hospital
state: Ibaraki
city: Toyomijo
country: Japan
facility: Yuaikai Toyomijo Chuo Hospital
state: Okinawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hirakata Hospital
state: Osaka
city: Suita
country: Japan
facility: Osaka University Dental Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Kagoshima
country: Japan
facility: Kagoshima University Medical and Dental Hospital
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daini Hospital
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Kitano Hospital, The Tazuke Kofukai Medical Research Institute
city: Osaka
country: Japan
facility: Osaka Police Hospital
city: Osaka
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
Study officials:
References:
citation: Inagaki Y, Morita K, Ozaki M, Matsumoto K, Okayama A, Oya N, Hiraoka T, Takeda J. The Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan. Yonago Acta Med. 2022 Jan 21;65(1):26-43. doi: 10.33160/yam.2022.02.005. eCollection 2022 Feb.