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Effect of intratheal fentanyl on sedation conducted by dexmedetomidne infusion

Effect of intratheal fentanyl on sedation conducted by dexmedetomidne infusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005162
Enrollment
82
Registered
2020-06-24
Start date
2017-10-25
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

None listed

Interventions

Drug : We will enroll 82 patients with American Society of Anesthesiologists physical status 1-2. The surgery limit orthopedic surgery of lower extremity knee operation such as arthroscopy procedure,
Group BO: 0.5 &#37
bupivacaine 10mg mix with normal saline 0.2ml group, Group BF: 0.5&#37
bupivacaine 10mg with 20ug fentanyl group. -The drugs are prepared an anesthesiologist who does not involved anesthesia and the other anesthesiologist who does not know about the drugs prepared, cond

Sponsors

Keimyung University Dongsan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -The patient are enrolled for spinal anesthesia, as American Society of Anesthesiologists physical status 1-2. The patients did not take sedatives for sleep and opioids as pain killer. -The patients who did not refuse for this study, are enrolled. Age of the patients enrolled for this study are between 50~70 years old. -The surgery limit orthopedic surgery of lower extremity knee operation such as arthroscopy procedure, total knee replacement or ankle arthroscopy which are proper for spinal anesthesia. - Patients who have abnormality of heart or repiratory system which increase risk of hypotension or hypoxia during sedation, is excluded.

Exclusion criteria

Exclusion criteria: Exclusion criteria are such as the patients with respiratory disease who did not reveal oxygen saturation within normal limits or who have lumbar surgery and have difficulty with spinal anesthesia, and who have uncontrolled hypertension, or cardiac disease. There are also excluded the patients who have infection at the site of spinal anesthesia, or who have bleeding tendency to increase spinal hematoma.

Design outcomes

Primary

MeasureTime frame
total dose of dexmedetomidine for sedation

Secondary

MeasureTime frame
BIspectral index (BIS) scale;Observerlertness of Sedation Scale (OASS),;mean arterial pressure,;heart rate;Use of ephedrine;Use of atropine;Use of nicardipine

Countries

Korea, Republic of

Contacts

Public ContactKibeom Park

Keimyung University Dongsan Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026