Effect of ultra-low-dose naloxone on intrathecal opioid-induced respiratory depression in cesarean delivery: a double-center prospective controlled trial

Effect of ultra-low-dose naloxone on intrathecal opioid-induced respiratory depression in cesarean delivery: a double-center prospective controlled trial - Effect of ultra-low-dose naloxone on opioid-induced respiratory depression

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030016

Enrollment

100

Registered

2017-11-20

Start date

2017-11-20

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

Hypoxia

Interventions

After delivery of the baby, the paitents are randomized to receive ultra-low-dose naloxone. After delivery of the baby, the paitents are randomized to receive saline.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) ASA physical status 2-3 ptients who presented for elective cesarean delivery under spinal anesthesia 2) Written informed consent is obtained from beach patients enrolled in the study.

Exclusion criteria

Exclusion criteria: 1) Emergency cesarean delivery 2) Allergy to naloxone, pentazocine, morphine, fentanyl, bupivacaine or lebobupivacaine

Design outcomes

Primary

Measure	Time frame
The incidence of opioid-induced respiratory depression within the first 24hr after administration of intrathecal opioids.	—

Countries

Japan

Contacts

Public ContactNoritaka Imamachi

Shimane University Faculty of Medicine Department of Anesthesiology

imamachi@med.shimane-u.ac.jp0853-20-2295

Outcome results

None listed

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