Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05719506
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2023-01-20
Brief Title:
A Comparative Evaluation of Nebulized Dexmedetomidine and Nebulized Ketamine as a Premedication in Pediatric Surgeries
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
A Comparative Evaluation of Nebulized Dexmedetomidine and Nebulized Ketamine as a Premedication in Pediatric Surgeries
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
preoperative anxiety and parental deprivation can be a traumatic time for young children undergoing surgery and remain challenges to anesthesiologists Preoperative anxiety stimulates the sympathetic parasympathetic and endocrine systems leading to an increase in heart rate HR blood pressure and cardiac excitability Pediatric anesthesiologists strive to minimize distress for children in the operating room OR environment and to provide a smooth induction of anesthesia
Detailed Description:
This prospective double-blind randomized controlled study will be carried out in Tanta University Hospitals in Anesthesia Department from July 2021 to december 2021 on pediatric patients undergoing surgeries
A written informed consent will be obtained from all patient parents who will receive an explanation to the purpose of the study and will have a secret code number to ensure privacy to participants and confidentiality of data
Research results will be only used for scientific purposes Procedures will be approved by both the Institutional and the Regional ethical committees
Any unexpected risk appears during the course of the research will be cleared to the participants and ethical committee on time and proper measures will be taken to overcome or minimize these risks
Randomization will be performed using the sealed opaque envelope technique each patients parent randomly selected a sealed envelope containing a group number in which the patient will be enrolled
The sample size was calculated based on the following criteria
95 confidence limit
95 power of the study
The groups ratio is 111
Based on a previous study 18 patients in each group should be sufficient to detect a difference between means of the Ramsay sedation scale of 06 and a common standard deviation of 048
2 cases were added to each group to overcome dropout Therefore we will recruit 20 cases in each group
Anesthetic management Preoperative assessment
Which will include
1 History
Clinical information such as age gender weight and other comorbidities will be evaluated
Take an AMPLE history allergies medications past medical anesthesia history last meal events leading up to the presentation and ask about family history of problems with anesthesia
2 Clinical examination Detailed airway assessment will be done
3 Laboratory investigations Complete blood picture bleeding time and clotting time All patients will be fasting for 2hr for clear fluids and 6-8 hr for solids
Premedication
In PACU All the children will be monitored for heart rate pulse oximetery and non-invasive blood pressure All the baseline parameter will be observed and recorded
Randomization
Using sealed envelopes patients will be assigned randomly to three groups n20 group that receive nebulized dexmedetomidine 3 μgkg group D nebulized ketamine 3mgkg group K control group nebulized normal saline without drug group C The drugs will be prepared in 09 normal saline to a final volume of 3ml Nebulization will be performed using a wall nebulizer and wall oxygen source on 4 lmin A Research nurse who will not participate in the evaluation of sedation administered the drugs to all children in nebulizer sessions 30 min before transfer to the OR
Patients will be assessed for sedation score then separated from their parents and the ease of separation will be recorded
In the OR
Children will receive standard monitoring including ECG capnogram noninvasive arterial blood pressure measurement and pulse oximetry
Induction
Induction of anesthesia will be done by inhalation of 8 sevoflurane in 100 oxygen by anesthesia circuit followed by the establishment of an intravenous peripheral line then iv fentanyl 1μgkg and atracurium initial dose 05 mg kg will be given and endotracheal tube will be inserted Anesthesia will be maintained with 2 sevoflurane in a mixture of 50 air and 50 O2 to keep the end-tidal carbon dioxide pressure PaCo2 between 30 and 35 mmHg and maintainence dose of atracurium 01 mg kg When the surgery will end sevoflurane discontinue and residual neuromuscular blockade will be antagonized with IV atropine 002 mgkg and IV prostigmine 005 mgkg then tracheal extubation will be done and recovery time will be recorded All patients will be transferred to PACU after tracheal extubation and discharge time will be recorded
A written informed consent will be obtained from all patient parents who will receive an explanation to the purpose of the study and will have a secret code number to ensure privacy to participants and confidentiality of data
Research results will be only used for scientific purposes Procedures will be approved by both the Institutional and the Regional ethical committees
Any unexpected risk appears during the course of the research will be cleared to the participants and ethical committee on time and proper measures will be taken to overcome or minimize these risks
Randomization will be performed using the sealed opaque envelope technique each patients parent randomly selected a sealed envelope containing a group number in which the patient will be enrolled
The sample size was calculated based on the following criteria
95 confidence limit
95 power of the study
The groups ratio is 111
Based on a previous study 18 patients in each group should be sufficient to detect a difference between means of the Ramsay sedation scale of 06 and a common standard deviation of 048
2 cases were added to each group to overcome dropout Therefore we will recruit 20 cases in each group
Anesthetic management Preoperative assessment
Which will include
1 History
Clinical information such as age gender weight and other comorbidities will be evaluated
Take an AMPLE history allergies medications past medical anesthesia history last meal events leading up to the presentation and ask about family history of problems with anesthesia
2 Clinical examination Detailed airway assessment will be done
3 Laboratory investigations Complete blood picture bleeding time and clotting time All patients will be fasting for 2hr for clear fluids and 6-8 hr for solids
Premedication
In PACU All the children will be monitored for heart rate pulse oximetery and non-invasive blood pressure All the baseline parameter will be observed and recorded
Randomization
Using sealed envelopes patients will be assigned randomly to three groups n20 group that receive nebulized dexmedetomidine 3 μgkg group D nebulized ketamine 3mgkg group K control group nebulized normal saline without drug group C The drugs will be prepared in 09 normal saline to a final volume of 3ml Nebulization will be performed using a wall nebulizer and wall oxygen source on 4 lmin A Research nurse who will not participate in the evaluation of sedation administered the drugs to all children in nebulizer sessions 30 min before transfer to the OR
Patients will be assessed for sedation score then separated from their parents and the ease of separation will be recorded
In the OR
Children will receive standard monitoring including ECG capnogram noninvasive arterial blood pressure measurement and pulse oximetry
Induction
Induction of anesthesia will be done by inhalation of 8 sevoflurane in 100 oxygen by anesthesia circuit followed by the establishment of an intravenous peripheral line then iv fentanyl 1μgkg and atracurium initial dose 05 mg kg will be given and endotracheal tube will be inserted Anesthesia will be maintained with 2 sevoflurane in a mixture of 50 air and 50 O2 to keep the end-tidal carbon dioxide pressure PaCo2 between 30 and 35 mmHg and maintainence dose of atracurium 01 mg kg When the surgery will end sevoflurane discontinue and residual neuromuscular blockade will be antagonized with IV atropine 002 mgkg and IV prostigmine 005 mgkg then tracheal extubation will be done and recovery time will be recorded All patients will be transferred to PACU after tracheal extubation and discharge time will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None