Clinical trial NCT01438957: Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia 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 With Epidural Anesthesia or Spinal Anesthesia Without Intubation Under Monitored Sedation Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedation
Keywords: Dexmedetomidine
Sedation
Non-intubation
epidural anesthesia
spinal anesthesia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Maruishi Pharmaceutical
First posted: 2011-09-22
Enrollment: 119
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 examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia 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 with spinal or epidural anesthesia 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.
4. Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation under monitored sedation care.
5. Patient undergoing a surgery requiring epidural or spinal 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 general anesthesia.
5. Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.
6. Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used in the study are contraindicated.
7. Patient diagnosed with unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
8. Patient whose heart rate is \<60 bpm, systolic blood pressure is \<90 mmHg by the physical examination prior to the study drug administration.
9. Patient has third degree heart block, unless the patient has a pacemaker or transverse pacing wires are in place.
10. 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.
11. Pregnant or lactating woman.
12. In the Investigator's or subinvestigator's opinion, the patient has any symptom or condition which might increase risk to the patient by conducting the study or preclude obtaining satisfactory study data

Primary outcomes:
measure: Percentage 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 after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Secondary outcomes:
measure: Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
timeFrame: 15 minutes after the start of study drug, if the OAA/S score is 5.
measure: Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
timeFrame: 15 minutes after the start of study drug, if the OAA/S score is 5.
measure: Time to First Rescue Administration of Propofol
timeFrame: During the study drug infusion period (≥15 minutes [Approximate])
measure: Percentage 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: Number of Fentanyl Dosing Required During the Study Drug Administration.
timeFrame: During the study drug administration
measure: Dosage of Fentanyl Dosing Required During the Study Drug Administration.
timeFrame: During the study drug administration
measure: Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion
timeFrame: Pre-dose, every 5 ± 2 minutes after start of 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 after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
measure: Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion
timeFrame: Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8.
measure: Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level)
timeFrame: Within 24 hours after completion of the study drug administration
measure: Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State)
timeFrame: Within 24 hours after completion of the study drug administration
measure: Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State)
timeFrame: Within 24 hours after completion of the study drug administration
measure: Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation)
timeFrame: Within 24 hours after completion of the study drug administration
measure: Score Evaluation of Satisfaction and Anxiety of the Subject ("I Was Satisfied With This Anesthesia Procedure")
timeFrame: Within 24 hours after completion of the study drug administration (as much as possible)
measure: Score Evaluation of Satisfaction and Anxiety of the Subject ("I Did Not Feel Pain During the Surgery")
timeFrame: Within 24 hours after completion of the study drug administration (as much as possible)
measure: Score Evaluation of Satisfaction and Anxiety of the Subject ("If You May Undergo a Similar Surgery, the Same Anesthesia Procedure Will be Requested for the Next Time")
timeFrame: Within 24 hours after completion of the study drug administration (as much as possible)
measure: Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level Before Surgery")
timeFrame: Within 24 hours after completion of the study drug administration (as much as possible)
measure: Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level During Surgery")
timeFrame: Within 24 hours after completion of the study drug administration (as much as possible)
measure: Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery")
timeFrame: Within 24 hours after completion of the study drug administration (as much as possible)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Nangoku
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
city: Matsumoto
country: Japan
facility: Shinshul University Hospital
state: Nagano
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
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: Tokyo
country: Japan
facility: Nippon Medical University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Inagaki Y, Yamakage M, Sakamoto A, Okayama A, Oya N, Hiraoka T, Morita K. The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study. Yonago Acta Med. 2022 Jan 4;65(1):14-25. doi: 10.33160/yam.2022.02.002. eCollection 2022 Feb.