Condition 1: anesthesia. Condition 2: sedation.
Conditions
Interventions
Intervention 1: Intervention group: The first group: midazolam half mg / kg (midazolam ampoule made by Caspian Tamin Company Rasht - Iran) after calculating the amount of drug based on the weight of t
Sponsors
Arak University of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Years to 10 Years
Inclusion criteria
Inclusion criteria: Age 2 to 7 years Weight between 10 and 30 kg ASA I or II Candidate for elective surgery except for fractures Absence of any fracture operation No history of allergies Absence of liver, kidney and cardiopulmonary disorders Lack of long-term use of anticonvulsant drugs, sleep disorders Absence of speech or communication problems Absence of gastrointestinal disorders (due to oral administration of drugs) The duration of surgery is less than 120 minutes Consent of parents and guardians of the child
Exclusion criteria
Exclusion criteria: Any unpredictable complications around the operation that affect the variables being evaluated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation score. Timepoint: The observation sedation score is measured before the medication is prescribed (midazolam, ketamine, and dexmedetomidine) and then when the child is separated from the parents. Method of measurement: Determine the sedation score by observing based on scoring from 1 to 5 based on the table from 1 to 5, respectively: agitated, alert, calm, drowsy and asleep.;Ease of separation score. Timepoint: When separating children from their parents. Method of measurement: Determining the ease of separation score by observation based on scoring from 1 to 4 according to the table from 1 to 4, respectively: unafraid and cooperative - slight fear or crying quiet with assurance - moderate fear, crying not quiet with assurance - crying, need for restraint.;Acceptance of drug. Timepoint: When inducing anesthesia inside the operating room. Method of measurement: Children are transported into the operating room and then inhaled anesthesia with a mask is induced in all groups using soufflore gas (4-8%). The acceptance rate of induction of anesthesia is determined based on the scoring of the table. Respectively from 1 to 3: refused to accept - accept with difficulty - accept without complaining. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects (nausea and vomiting, hypotension, bradycardia). Timepoint: In the postoperative period, patients will be monitored and followed for 24 hours for possible side effects. Method of measurement: Nausea and vomiting with observation and examination - Hypotension (low blood pressure more than 20% of primary blood pressure) with arm sphygmomanometer - Bradycardia (heart rate less than 70 beats per minute) with heart monitoring and finger pulse oximetry.;Time to get Aldrete Score 8 and above. Timepoint: One turn (after the end of the operation until reaching the Aldrete score 8 and above). Method of measurement: In minutes from the end of the operation until reaching the Aldrete score of 8 and above In the recovery room according to the table The Modified Aldrete Postanesthesia Score in pediatric.;Mean blood pressure. Timepoint: Under monitoring from 30 minutes before anesthesia, every 5 minutes from the time of sedation until induction of anesthesia, every 15 minutes throughout the operation and in recovery until full awakening, re-measured in case of side effects up to 24 hours after surgery. Method of measurement: arm sphygmomanometer In millimetres of mercury.;Heart rate. Timepoint: Under monitoring from 30 minutes before anesthesia, every 5 minutes from the time of sedation until induction of anesthesia, every 15 minutes throughout the operation and in recovery until full awakening, re-measured in case of side effects up to 24 hours after surgery. Method of measurement: Cardiac monitoring and finger pulse oximetery.;Arterial oxygen saturation. Timepoint: Under monitoring from 30 minutes before anesthesia, every 5 minutes from the time of sedation until induction of anesthesia, every 15 minutes throughout the operation and in recovery until full awakening, re-measured in case of side effects up to 24 hours after surgery. Method of measurement: Finger pulse oximetery. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHesameddin Modir
Arak University of Medical Sciences
Outcome results
None listed