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

Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438957
• Other study ID #: DEX-303
• Status: Completed
• Phase: Phase 3
• Start date: June 3, 2011
• Est. completion date: November 18, 2011

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 18, 2011
• Est. primary completion date: November 18, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
• Placebo

Locations

Country	Name	City	State
Japan	Asahikawa Medical University Hospital	Asahikawa	Hokkaido
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Japanese Red Cross Kyoto Daini Hospital	Kyoto
Japan	Shinshul University Hospital	Matsumoto	Nagano
Japan	University of Miyazaki Hospital	Miyazaki
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Kochi Medical School Hospital	Nangoku	Kochi
Japan	Okayama University Hospital	Okayama
Japan	Kitano Hospital, The Tazuke Kofukai Medical Research Institute	Osaka
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Nippon Medical University Hospital	Tokyo
Japan	Tottori University Hospital	Yonago	Tottori

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Maruishi Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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	Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score =4 During the Study Drug Administration		15 minutes after the start of study drug, if the OAA/S score is 5.
Secondary	Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score =4 During the Study Drug Administration		15 minutes after the start of study drug, if the OAA/S score is 5.
Secondary	Time to First Rescue Administration of Propofol		During the study drug infusion period (=15 minutes [Approximate])
Secondary	Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration		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.
Secondary	Number of Fentanyl Dosing Required During the Study Drug Administration.		During the study drug administration
Secondary	Dosage of Fentanyl Dosing Required During the Study Drug Administration.		During the study drug administration
Secondary	Percentage of Time Spent OAA/S Score =4 During the Study Drug Infusion		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	Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion		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	Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion		Every 15 ± 2 minutes until the score of each item becomes =1 and the total value becomes =8.
Secondary	Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level)	VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.	Within 24 hours after completion of the study drug administration
Secondary	Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State)	VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.	Within 24 hours after completion of the study drug administration
Secondary	Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State)	VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.	Within 24 hours after completion of the study drug administration
Secondary	Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation)	VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.	Within 24 hours after completion of the study drug administration
Secondary	Score Evaluation of Satisfaction and Anxiety of the Subject ("I Was Satisfied With This Anesthesia Procedure")	Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.	Within 24 hours after completion of the study drug administration (as much as possible)
Secondary	Score Evaluation of Satisfaction and Anxiety of the Subject ("I Did Not Feel Pain During the Surgery")	Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.	Within 24 hours after completion of the study drug administration (as much as possible)
Secondary	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")	Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.	Within 24 hours after completion of the study drug administration (as much as possible)
Secondary	Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level Before Surgery")	Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.	Within 24 hours after completion of the study drug administration (as much as possible)
Secondary	Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level During Surgery")	Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.	Within 24 hours after completion of the study drug administration (as much as possible)
Secondary	Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery")	Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.	Within 24 hours after completion of the study drug administration (as much as possible)