Effect of Oral Dexmedetomidine, Ketamine, Or Midazolam as Preioperative Medications.

NCT ID: NCT05874245

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-03-01

Brief Summary

Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. The premedication must be administered in a manner that is safe, painless, and without significant adverse effects.

In children, the incidence of emergency agitation or delirium after general anesthesia ranges from 10% to 80% and significantly increases the incidence of other complications after anesthesia, such as self-injury, prolonged postanesthesia care unit (PACU) stay, frustration of parents and care providers.

Numerous pharmacological and non-pharmacological techniques, including sedative premedication, parental presence, and training programs for participants and their parents, have been investigated to reduce anxiety and enhance compliance during anesthesia induction.

An ideal premedication prescription should sedate a child to facilitate separation from parents, thus simplifying anesthesia induction and creating a pleasant surgical experience for both children and parents. [5]

Anxiolysis is the major objective of premedication in children, as it facilitates separation from parents and facilitates the induction of anesthesia.

Premedication may also induce amnesia, the prevention of physiologic stress, vagolysis, a decrease in total anesthetic requirements, a lower likelihood of aspiration, decreased salivation and secretions, antiemesis, and analgesia. All drugs have the potential to make people sleepy and slow their breathing, so they must be given with extreme care and closely watched.

Ketamine is a useful sedative and analgesic for preventing preoperative anxiety in children; it exerts its analgesic effect through the reversible antagonist action of N-methyl-D-aspartate receptors. It has analgesic and sedative effects in different doses of administration. Ketamine is often administered orally and is αreported to be safe and effective in pediatric patients.

An effective sedative and analgesic with minimal respiratory depressive effects is dexmedetomidine, an α2-adrenoceptor agonist. It also reduces the hemodynamic stress response due to its sympatholytic effect. These characteristics make it a possible anesthetic premedication.

Midazolam, a water-soluble benzodiazepine, is commonly used as a preanesthetic medicine in children due to its several favorable effects: sedation, anxiolysis, antegrade amnesia, rapid onset, and brief duration of action.

Adenoidectomy and/or tonsillectomy are the most common surgical procedures done on children.

Hence, the present study will be conducted to objectively evaluate, the perioperative effects of oral dexmedetomidine, ketamine, or midazolam premedication in patients undergoing adenotonsillectomy.

Detailed Description

Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. The premedication must be administered in a manner that is safe, painless, and without significant adverse effects.

In children, the incidence of emergency agitation or delirium after general anesthesia ranges from 10% to 80% and significantly increases the incidence of other complications after anesthesia, such as self-injury, prolonged postanesthesia care unit (PACU) stay, frustration of parents and care providers.

Numerous pharmacological and non-pharmacological techniques, including sedative premedication, parental presence, and training programs for participants and their parents, have been investigated to reduce anxiety and enhance compliance during anesthesia induction.

An ideal premedication prescription should sedate a child to facilitate separation from parents, thus simplifying anesthesia induction and creating a pleasant surgical experience for both children and parents.

Anxiolysis is the major objective of premedication in children, as it facilitates separation from parents and facilitates the induction of anesthesia.

Premedication may also induce amnesia, the prevention of physiologic stress, vagolysis, a decrease in total anesthetic requirements, a lower likelihood of aspiration, decreased salivation and secretions, anti-emesis, and analgesia. All drugs have the potential to make people sleepy and slow their breathing, so they must be given with extreme care and closely watched.

Ketamine is a useful sedative and analgesic for preventing preoperative anxiety in children; it exerts its analgesic effect through the reversible antagonist action of N-methyl-D-aspartate receptors. It has analgesic and sedative effects in different doses of administration. Ketamine is often administered orally and is αreported to be safe and effective in pediatric patients.

An effective sedative and analgesic with minimal respiratory depressive effects is dexmedetomidine, an α2-adrenoceptor agonist. It also reduces the hemodynamic stress response due to its sympatholytic effect. These characteristics make it a possible anesthetic premedication. Midazolam, a water-soluble benzodiazepine, is commonly used as a preanesthetic medicine in children due to its several favorable effects: sedation, anxiolysis, antegrade amnesia, rapid onset, and brief duration of action.

Adenoidectomy and/or tonsillectomy are the most common surgical procedures done on children.

Hence, the present study will be conducted to objectively evaluate, the perioperative effects of oral dexmedetomidine, ketamine, or midazolam premedication in patients undergoing adenotonsillectomy.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Group D; oral Dexmedetomidine

will receive 4 micrograms/kg oral Dexmedetomidine diluted in paracetamol \[Paracetamol syrup 150 mg/5ml\] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia.

Group Type: EXPERIMENTAL

oral Dexmedetomidine

Intervention Type: DRUG

will receive 4 micrograms/kg oral Dexmedetomidine diluted in paracetamol \[Paracetamol syrup 150 mg/5ml\] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia

Group K; oral ketamine group

will receive 6 mg/kg oral Ketamine diluted in paracetamol \[Paracetamol syrup 150 mg/5ml\] at a dose of 15 mg/kg 45 minutes before the induction of anaesthesia.

Group Type: EXPERIMENTAL

oral ketamine

Intervention Type: DRUG

will receive 6 mg/kg oral ketamine diluted in paracetamol \[Paracetamol syrup 150 mg/5ml\] at a dose of 15 mg/kg 45 minutes before the induction of anaesthesia

Group M; oral Midazolam group

will receive 0.3 mg/kg (maximum 20 mg) oral Midazolam diluted in paracetamol \[Paracetamol syrup 150 mg/5ml\] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia.

Group Type: EXPERIMENTAL

oral Midazolam

Intervention Type: DRUG

will receive 0.3 mg/kg (maximum 20 mg) oral Midazolam diluted in paracetamol \[Paracetamol syrup 150 mg/5ml\] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia

Interventions

oral Dexmedetomidine

will receive 4 micrograms/kg oral Dexmedetomidine diluted in paracetamol \[Paracetamol syrup 150 mg/5ml\] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia

Intervention Type: DRUG

oral ketamine

will receive 6 mg/kg oral ketamine diluted in paracetamol \[Paracetamol syrup 150 mg/5ml\] at a dose of 15 mg/kg 45 minutes before the induction of anaesthesia

Intervention Type: DRUG

oral Midazolam

will receive 0.3 mg/kg (maximum 20 mg) oral Midazolam diluted in paracetamol \[Paracetamol syrup 150 mg/5ml\] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All patients within the age range of 3 to 8 years old.
• Elective non complicated adenotonsillectomy.
• ASA I or II physical status.

Exclusion Criteria

• Refusal of the patient's parents or legal guardians to give informed consent.
• History of allergy to any of the study drugs.
• Preoperative intake of opioid or non-steroidal anti-inflammatory drugs within 24 h before surgery.
• Neurological and/or psychological diseases.
• Associated cardio-respiratory illness

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed elsayed mahmoud abousayar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Menoufia university hospitails

Shibīn al Kawm, Menoufia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Abosayar, Assisstant lecturer

Role: CONTACT

Aabosayar@gmail.com

+201064070141

Other Identifiers

11\2022 ANES 15

Identifier Type: -

Identifier Source: org_study_id