Effects of administration temperature and gender on the effects of atracurium dibesilate (tracrium).

Effects of administration temperature and gender on the pharmacokinetics of atracurium dibesilate (tracrium).

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23286

Enrollment

126

Registered

2013-02-11

Start date

2012-12-01

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

general Anesthesia Atracurium dibesilaat Tracrium

Interventions

Patients are divided into two groups and either receive atracurium directly at room temperature (20 degrees) or refrigerator temperature (2-8 degrees). The duration of the intervention stops directly

Eligibility

Inclusion criteria

Inclusion criteria: 1. Atracurium dose during induction 0,23mg/kg; 2. Age between 18 and 80 yrs; 3. Mentally competent; 4. Elective surgery; 5. BMI between 20 and 35; 6. Perioperative temperature between 35 and 38 degrees C; 7. Perioperative normoventilation (EtCO2 between 32 and 40mmHg); 8. Train of Four measurement on dominant side of the patient.

Exclusion criteria

Exclusion criteria: 1. Fever; 2. Use of succinyl; 3. Hypokaliemie (< 3,3); 4. Dehydration; 5. Clotting diseases; 6. Peri-operative ketamine; 7. Pre operative use of fenytoine or carbamazepine.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics of atracurium, measured at 1, 5, 10, 15 30, 45 and 60 minutes with the train of four.	—

Secondary

Measure	Time frame
1. Does atracurium administered between 2-8 degrees Celsius change TOF; 2. Does atracurium administered between 2-8 degrees Celsius over atracurium at room temperature (21 degrees) change its working profile; 3. Is the intensity measured after train of four 1, 5, 10, 15, 30, 45 and 60 minutes after administration of atracurium of 2-8 degrees higher than in the atracurium at room temperature (20 degrees); 4. Is there any difference between gender on secondary outcomes?	—

Measure

Time frame

1. Does atracurium administered between 2-8 degrees Celsius change TOF; 2. Does atracurium administered between 2-8 degrees Celsius over atracurium at room temperature (21 degrees) change its working profile; 3. Is the intensity measured after train of four 1, 5, 10, 15, 30, 45 and 60 minutes after administration of atracurium of 2-8 degrees higher than in the atracurium at room temperature (20 degrees); 4. Is there any difference between gender on secondary outcomes?

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Contacts

Public ContactH. Zonneveldt

Westfriesgasthuis Maeslonstraat 4

h.zonneveldt@westfriesgasthuis.nl+31 (0)229 208562

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)