Hemodynamic stability during anesthesia induction with ketofol mixture – identifying optimal ratio

• Register: ISRCTN
• Last refreshed on: 4 September 2017
• Main ID: ISRCTN59349598
• Date of registration: 02/08/2017
• Prospective Registration: No
• Primary sponsor: University Clinical Centre Maribor
• Public title: Hemodynamic stability during anesthesia induction with ketofol mixture – identifying optimal ratio
• Scientific title: Hemodynamic stability during anesthesia induction with propofol/esketamine (ketofol) mixture – identifying optimal ratio
• Date of first enrolment: 01/08/2017
• Target sample size: 100
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN59349598
• Study type: Interventional
• Study design: Randomised double blind controlled parallel trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Slovenia

Contacts

• Name: Domen Kogler

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18-80 years
2. ASA Physical Status I or II
3. Elective surgery with orotracheal intubation
Exclusion criteria: 1. Allergy or sensitivity to any medication used in trial
2. Alcohol or drug abuse
3. Chronical use of benzodiazepins, opiats or psyhothrophic medication
4. Body mass index higher than 35 or lower than 15
5. Anticipated difficult intubation (Mallampati III or IV)
6. Untreated arterial hypertension
7. Patients with Alzheimers, epilepsy or psychosis

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Elective surgery with orotracheal intubation
Surgery
Elective surgery with orotracheal intubation

Intervention(s)

Participants undergoing elective surgery are randomly allocated to one of three groups. Randomisation is done by an independent person using a draw. The following groups are:

Group K1: Participants in this group receive an anesthetic mixture of 10 ml 1% propofol and 4 ml 2,5% esketamine

Group K2: Participants in this group receive an anesthetic mixture mixture of 10 ml 1% propofl, 2 ml 2,5% esketamine and 2 ml 0,9% NaCl solution

Group P: Participants in this group receive an anesthetic mixture of 10 ml 1% propofol and 4 ml 0,9% NaCl solution (control)

All participants are premedicated with midazolam one hour before surgery. All patients follow the same protocol for first 16 minutes, the only variable is anaesthetic mixture. Anaesthesia induction starts at time 0 when patient gets 0,25 mcg/kg of sufentanyl (concentration 5 mcg/ml, rounded to nearest ml). At 120 seconds all participants receive 5 ml bolus of anaesthetic mixture following titration with 1 ml until clinical effect (lose of palpebral efect). Then 0,6 mg/kg (concentration 10mg/ml, rounded to nearest ml) is administered to patient following another 2ml of anaesthetic mixture. Between minute 4 and 5 (time 240 s to 300 s) the patient is intubated and then mechanically ventilated, maintaining anesthesia with sevoflurane 1,0-1,5 vol%.

Dosing is titrated to clinical effect (lose of palpebral effect) with blinded recording of Bispectral index.

Total duration of treatment is one hour before surgery (premedication) untill one hour after surgery (recovery from anaesthesia) for all treatment arms (sturdy groups). Duration of data collection study is first 16 minutes after application of sufentanyl (start of anaesthesia induction). Follow up is the same for all treatments arms and ends one hour after surgery (recovery from anaesthesia).

Primary Outcome(s)

1. Cardiac output is measured noninvasively using transthoracal electric bioimpedance every minute for first 16 minutes after induction of anesthesia
2. Blood pressure is measured noninvasively using arm cuffs every 2 minutes for first 16 minutes after induction of anesthesia
3. Heart rate is measured by ECG every minute for first 16 minutes after induction of anesthesia

Secondary Outcome(s)

1. Bispectral index (BIS) (depth of sedation or anaesthesia) is monitored with 15 seconds sampling using forehead electrodes every minute for first 16 minutes after induction of anesthesia.
2. Dose titrated to clinical effect (loss of palpebral effect)

Secondary ID(s)

KME 39/08/16

Source(s) of Monetary Support

University Clinical Centre Maribor