Sleep Apnea Syndromes
Conditions
Brief summary
The investigator compared the sedative effects of propofol alone and ketamine added to propofol in drug induced sleep endoscopy
Detailed description
Propofol and ketamineare commonly used intravenous anesthetic drug used for procedural sedation. The investigator compared the effect of propofol and propofol ketamine in patients undergoing drug induced sleep endoscopy.
Interventions
effect of adding ketamine to propofol for patients undergoing DISE surgery
DRUGpropofol
effect of IV propofol alone for patients undergoing DISE surgery
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years old. * American society of anesthesiologists (ASA) physical status I or II. I / II
Exclusion criteria
* patient refusal * American society of anesthesiologists (ASA) physical status \> III * known or suspected allergy to the studied drugs or its components, allergy to eggs or soy beans * morbid obesity * patients with moderate to severe chronic obstructive pulmonary disease or uncontrolled asthma, congestive e heart failure ,seizures ,or cerebrovascular disease * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction) | the duration of the procedure under sedation is usually about 20 minutes to complete the procedure | Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The total propofol and ketamine dose(mg)/patient needed/patient was calculated | the procedure | The total propofol and ketamine(mg) /patient dose needed/patient was calculated |
| any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction | the procedure | Once the DISE began, the airway interventions were important as outcomes, because these interrupted the clinical study of the DISE. Furthermore, laryngospasm was defined by the requirement for positive pressure ventilation of \>20 cmH2O or administration of succinylcholine or propofol or any . |
| Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reflex, apnea or aspiration) were recorded during the procedure | the procedure | Bradycardia was diagnosed if heart rate dropped below 60beats/min and atropine 0.01mg/kg was given if HR decreased below 50beats/min. Hypotension was diagnosed if mean arterial blood pressure (MAP) decreased by more than 30% from baseline or below 60mmHg |
| time until sufficient sedation to start endoscopy | It is about 5-10 minutes from start of studied drug till patient is ready to start endoscopy | time to start endoscopy is defined as the duration between start of the studied drugs until MOAA/S Modified observer assessment scale of alertness sedaion score 1 was obtained. |
| patients and surgeon satisfaction | about 30 minutes after complete recovery both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied | Both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied |
| Time to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure in the recovery room | Average 15-30 minutes post procedure to have Aldrete's recovery scores 10 (maximum) (patient is ready to discharge) in the recovery room | Time to Aldrete's recovery scores became 10 (maximum)(patient is ready to discharge) was recorded post procedure in the recovery room |
| Time till Recovery | an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4 | Time between stop of the study drugs until Modified observer's assessment of alertness sedation MOAA/S score of 4 was calculated and patient is shifted to recovery room( MOAA/S score btween 0-6 where 1 patient is ready for endoscopic airway evaluation and 1 patient is ready for discharge to recovery room ) Time till (MOAA/S) score 4 was calculated . |
Countries
Egypt
Contacts
Primary ContactHeba M EL-Asser, MD
Backup ContactHala A Mohamed, MD
Outcome results
None listed