A Phase 4 interventional study of Propofol Astrazeneca plain and Propofol Astrazeneca plus lidocaine in General Anesthesia, sponsored by Hopital Foch. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-26.
Sponsored by Hopital Foch · Phase 4, Interventional, and Treatment
The objective of this study is to evaluate the influence of different propofol formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with lidocaine is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.
Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.
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Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
Drug: Propofol Astrazeneca plain
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
Drug: Propofol Astrazeneca plus lidocaine
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
Drug: Propofol-lipuro B. Braun plain
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
Drug: Propofol-lipuro B. Braun plus lidocaine
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
Drug: Propofol Fresenius plain
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
Drug: Propofol Fresenius plus lidocaine
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
Also known as: Propofol Astrazeneca
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
Also known as: Propofol Astrazeneca, Lidocaine
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
Also known as: Propofol-lipuro B. Braun
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
Also known as: Propofol-lipuro B. Braun, lidocaine
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
Also known as: Propofol Fresenius
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
Also known as: Propofol Fresenius, lidocaine
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)
Time frame: end of anesthetic induction
calculated concentrations of propofol at the end of the anesthetic induction
Time frame: end of the anesthetic induction
measured plasma propofol concentrations at the end of anesthetic induction (in 20% of patients)
Time frame: 3 months after the end of patient's recruitment
pain at injection
Time frame: during the PACU (post-anaesthesia care unit) stay
heart rate and arterial pressure modifications induced by anesthetic induction
Time frame: end of anesthetic induction
patients satisfaction
Time frame: during the PACU stay
necessary dose of propofol to obtain loss of consciousness
Time frame: end of anesthetic induction
calculated concentrations of propofol at loss of consciousness
Time frame: end of anesthetic induction
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Hopital Foch