Comparison of anesthetic drugs to create deep sedation.

Compare the effects of low-dose combination of anesthetic drugs (including fentanyl, propofol, midazolam, ketamine and lidocaine) with the usual dose of propofol in creating deep sedation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015112525235N1

Enrollment

122

Registered

2016-11-04

Start date

2015-03-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Procedural Sedation and Analgesia.

Interventions

Intervention 1: Intervention group: Intervention group patients are given low doses of sedative drugs, including propofol in a dose of 0.5 mg per kilogram of body weight, ketamine 0.2 to 0.25 mg per

Treatment - Drugs

Intervention group: Intervention group patients are given low doses of sedative drugs, including propofol in a dose of 0.5 mg per kilogram of body weight, ketamine 0.2 to 0.25 mg per kilogram of bod

Control group: patients in control group are given propofol at a dose of 1 mg per kilogram and fentanyl 1 microgram per kilogram of body weight Intravenously .

Eligibility

Sex/Gender

All

Age

15 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients admitted to the emergency department of Emam Hossein hospital over 15 years to 60 years of age and they need Procedural sedation and analgesia (PSA) Exclusion criteria: previous allergy to drugs used in the study; sensitivity to egg or soy products; Hemodynamic Instability; pregnancy; drug interactions; increased intracranial pressure (ICP)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The needed time for recovery from deep sedation. Timepoint: Every 30 seconds since the beginning of deep sedation. Method of measurement: The interval time between induction of sedation (Ramsay score 6) and recovery (Ramsy score of 2.;The depth of sedation. Timepoint: Every 30 seconds since the beginning of sedation. Method of measurement: the depth of sedation according to the Ramsay score.;The time required to create deep sedation. Timepoint: Every 30 seconds. Method of measurement: Since the beginning of sedative drugs to achieve deep sedation (Ramsay score equal to 6).	—

Measure

Time frame

The needed time for recovery from deep sedation. Timepoint: Every 30 seconds since the beginning of deep sedation. Method of measurement: The interval time between induction of sedation (Ramsay score 6) and recovery (Ramsy score of 2.;The depth of sedation. Timepoint: Every 30 seconds since the beginning of sedation. Method of measurement: the depth of sedation according to the Ramsay score.;The time required to create deep sedation. Timepoint: Every 30 seconds. Method of measurement: Since the beginning of sedative drugs to achieve deep sedation (Ramsay score equal to 6).

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Secondary

Measure	Time frame
Cardiac arrhythmia. Timepoint: continuously since the beginning of sedation. Method of measurement: Cardiac monitoring.;Arterial blood pressure. Timepoint: Before prescription of drugs, then every 5 minutes until recovery time. Method of measurement: Using the sphygmomanometer.;Physician and patient's satisfaction. Timepoint: after the procedure. Method of measurement: By questionnaire.;Arterial blood oxygen saturation. Timepoint: Continuously since the beginning of sedation. Method of measurement: Pulse oximetry.;Vomiting. Timepoint: since the beginning of sedation until full recovery. Method of measurement: Observation.	—

Measure

Time frame

Cardiac arrhythmia. Timepoint: continuously since the beginning of sedation. Method of measurement: Cardiac monitoring.;Arterial blood pressure. Timepoint: Before prescription of drugs, then every 5 minutes until recovery time. Method of measurement: Using the sphygmomanometer.;Physician and patient's satisfaction. Timepoint: after the procedure. Method of measurement: By questionnaire.;Arterial blood oxygen saturation. Timepoint: Continuously since the beginning of sedation. Method of measurement: Pulse oximetry.;Vomiting. Timepoint: since the beginning of sedation until full recovery. Method of measurement: Observation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahram Shokrzadeh.MD

Shahid Beheshti University of Medical Science

shahram.shokrzadeh@gmail.com+98 21 73430

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026