A comparison of sedation with midazolam and remifentanil or dexmedetomidine and remifentanil during sling procedure

A comparison of sedation with midazolam and remifentanil or dexmedetomidine and remifentanil during transobturator sling procedure; A double-blind randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000159

Enrollment

Registered

2011-08-01

Start date

2011-08-01

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : For sedative titration, dexmedetomidine 1mcg/kg or midazolam 0.5 mg/kg for 10 minutes intravenos infusion. For analgesic titration, remifentanil is target-controlled infusion according to surgi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) scheduled for elective transobturator sling procedure for the treatment of urinary incontinence 2) female patient, 21 ~ 65 years old 3) volunteer for present clinical study

Exclusion criteria

Exclusion criteria: 1) the patient who do not agree to participate in present study 2) allergic history for midazolam, opioids, or dexmedetomidine 3) bradycardia (<50 bpm) hypotension (SBP <90 mmHg) 4) 2 or 3 degree heart block, acute myocardial ischemia, heart failure 5) drug addction history 6) pregnancy, hepatic or reneal disease

Design outcomes

Primary

Measure	Time frame
Bispectral Index;Recovery degree - Observer’s Assessment of Alertness/Sedation Scale(OAA/S);pain score (numeric rating score)	—

Secondary

Measure	Time frame
end tidal CO2;vital sign (blood pressure, heart rate, oxygensaturation);patient satisfaction;operator satisfaction	—

Countries

Korea, Republic of

Contacts

Public ContactEun Ha Suk

Asan Medical Center

Outcome results