Procedural Propofol Sedation with ketamine versus alfentanil and remifentanil.

Procedural Propofol Sedation with ketamine versus alfentanil and remifentanil in patients for pulmonary vein isolation.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29416

Enrollment

120

Registered

2014-06-07

Start date

2014-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

We evaluate the role of injection of ketamine as an analgesic component of anesthesia in comparison with the other analgesics (opioids) in procedural sedation and analgesia therapy (PSA) because of the increasing importance of physician’s satisfaction during performing procedures and patient’s comfort.

Interventions

For sedation, a propofol perfusor will be started combined with ketamine, even administered by perfusor. During the procedure, doses of propofol and ketamine will be fitted to the clinical situation,

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria are requirement for PSA, patients aged 18 years or older and with an American Society of Anesthesiology class 1 to 3. Patients will be included in this study after given written informed consent before the treatment starts.

Exclusion criteria

Exclusion criteria: Patients will be excluded form the study if they are unable to give informed consent, are pregnant, has a known allergy to either study medication, are receiving treatment for neuromuscular or psychiatric disease or has a physical or communicational disorder.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is physician’s satisfaction with the applied sedation technique, measured on a Likert five-item scoring system.	—

Secondary

Measure	Time frame
Observer’s Assessment of Alertness/ Sedation score, Ramsay score, hemodynamic parameters (mean heart rate, mean systolic blood pressure, mean diastolic blood pressure), respiratory parameters (mean Spo2 values, mean end-tidal co2 values, mean respiratory rated and number of apneas during the procedure), times (time of induction, time required for the procedure, sedation time and recovery time), total dosage of medication needed during the procedure, pain, Aldrete score, patients’ satisfaction and side effects (nausea, vomiting).	—

Measure

Time frame

Observer’s Assessment of Alertness/ Sedation score, Ramsay score, hemodynamic parameters (mean heart rate, mean systolic blood pressure, mean diastolic blood pressure), respiratory parameters (mean Spo2 values, mean end-tidal co2 values, mean respiratory rated and number of apneas during the procedure), times (time of induction, time required for the procedure, sedation time and recovery time), total dosage of medication needed during the procedure, pain, Aldrete score, patients’ satisfaction and side effects (nausea, vomiting).

—

Contacts

Public ContactF.H.J. Loon, van

Michelangelolaan 2

rick.v.loon@cze.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)