Dexmedetomidine Clinical Trial
Official title:
An Optimum Time for Intravenous Cannulation After General Anesthesia Induction With Sevoflurane and Nitrous Oxide in Children Undergoing Elective Surgery With Dexmedetomidine Premedication
Verified date | November 2021 |
Source | Karaman Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Inhalational induction with sevoflurane, nitrous oxide, and oxygen is accepted as a safe technique to avoid any movement during intravenous cannulation in children. In addition, intranasal dexmedetomidine could be used for premedication to reduce preoperative anxiety in preschool children. Early attempts to place, an intravenous line may result in movement and respiratory complications like coughing or laryngospasm. On the other hand delay in cannulation may prevent effective management of bradycardia and hypotension. There are a number of studies examining the optimum time for cannulation after sevoflurane induction. However, it is not known whether the addition of dexmedetomidine premedication affects the time for intravenous cannulation following induction with sevoflurane and nitrous oxide.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 4, 2022 |
Est. primary completion date | February 4, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 6 Years |
Eligibility | Inclusion Criteria: - Children with ASA physical status I and scheduled for an elective procedure under general anesthesia without prior intravenous cannulation will be selected Exclusion Criteria: - Children posted for any emergency procedure - ASA class II and above, - Children with abnormal airway anatomy. - Children with active respiratory infection in the last 3 weeks. - Children who are being treated with sedative or anticonvulsive agents. - Children with heart, lung, neurologic, or central nervous system disorders. |
Country | Name | City | State |
---|---|---|---|
Turkey | Karaman Taining and Research Hospital | Karaman |
Lead Sponsor | Collaborator |
---|---|
Karaman Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of optimum time for intravenous cannulation after induction with sevoflurane and nitrous oxide in children premedicated with dexmedetomidine | At the time of intravenous canulation attempt, an independent observer who will be blinded about predetermined canĂ¼lation time, rated the movement according to a scale (0= no movement 1= slight extremity tensing, 2= extremity withdrawal, 3=generalized movement.
Intravenous cannulation without any laryngospasm or movement will be considered successful. |
The outcome will be assessed at the time of intravenous cannulation attempt. | |
Secondary | To assess level of preoperative sedation | The level of sedation will be assessed with Ramsay Sedation Scale. This scale includes the following categories: 1, anxious, restless, or agitated; 2, cooperative; 3, responds to commands only; and 4-6, different levels of unconsciousness, where 6 indicates no response to a light glabellar tap or loud auditory stimulus. Higher scores denote higher levels of sedation. Assessment will be started from acceptance of the patient to the preoperative holding area (baseline) to the time when anesthesia preparation will occur. The children will be evaluated 3 times, at baseline, post-premedication 40th minute, and during anesthesia preparation in the operating room. | Assesment of children will be started from acceptance of patient to preoperative holding area to the time of anesthesia preparation. | |
Secondary | To assess level of preoperative anxiety | Anxiety will be measured at the time of arrival in the preoperative holding area (baseline) and during anesthesia preparation in the operating room. The level of anxiety will be assessed using the validated Turkish version of the modified Yale Preoperative Anxiety Scale (mYPAS), containing 27 items in five categories (activity, emotional, expressivity, state of arousal, vocalization, and use of parents), representing five domains ofanxiety.The mYPAS scale ranges from 0 to 100 points, with higher scores signifying higher levels of anxiety. Assessment will be started from acceptance of the patient to the preoperative holding area (baseline) to the time when anesthesia preparation will occur. The children will be evaluated 3 times, at baseline, post-premedication 40th minute, and during anesthesia preparation in the operating room. | Assesment of children will be started from acceptance of patient to preoperative holding area to the time of anesthesia preparation. |
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