Double blind study evaluating the efficacy and safety of DA-9501 in sedation during nonintubated surgery with epidural anesthesia or spinal anesthesia

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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221480

Enrollment

120

Registered

2011-06-15

Start date

2011-06-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient who requires sedation during nonintubated surgery with epidural anesthesia or spinal anesthesia

Interventions

investigational material(s) Generic name etc : DA-9501 INN of investigational material : dexmedetomidine Therapeutic category code : 112 Hypnotics and sedatives, antianxietics Dosage and Administratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient who requires sedation during the elective surgery which requires 30mins or more (expected time) without intubation. ASA I to III Class. Patient undergoing a surgery requiring epidural or spinal anesthesia.

Exclusion criteria

Exclusion criteria: Patient diagnosed unstable angina or acute myocardiac infarction within past 6 weeks. Patient whose heart rate less than 50 bpm, systolic blood pressure less than 90 mmHg. Patient has third degree heart block.

Design outcomes

Primary

Measure	Time frame
Incidence of patients who did not require rescue sedative to achieve and maintain adequate sedation level during the study drug administration. Incidence of patients who did not require rescue sedative is compared between each DA-9501 group and Placebo group.	—

Secondary

Measure	Time frame
Administration frequency and dosage of rescue sedative required to achieve and maintain adequate sedation level during the study drug administration. Administration frequency and dosage of rescue sedative are compared between each DA-9501 group and Placebo group. Incidence of patients who did not require rescue analgesia during the study drug administration. Incidence of patients who did not require rescue analgesia is compared between each DA-9501 group and Placebo group. Administration frequency and dosage of rescue analgesia during the study drug administration. Administration frequency and dosage of rescue analgesia are compared between each DA-9501 group and Placebo group.	—

Measure

Time frame

Administration frequency and dosage of rescue sedative required to achieve and maintain adequate sedation level during the study drug administration. Administration frequency and dosage of rescue sedative are compared between each DA-9501 group and Placebo group. Incidence of patients who did not require rescue analgesia during the study drug administration. Incidence of patients who did not require rescue analgesia is compared between each DA-9501 group and Placebo group. Administration frequency and dosage of rescue analgesia during the study drug administration. Administration frequency and dosage of rescue analgesia are compared between each DA-9501 group and Placebo group.

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Contacts

Public Contact; ;

Hospira Japan Co., Ltd.;Maruishi Pharmaceutical Co., Ltd.

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Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026