Urinary Tract Problem
Conditions
Keywords
Remifentanil, Laryngeal mask airway removal, Hemodynamic changing, Infusion, Ureterorenoscopy
Brief summary
The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated.
Detailed description
In all patients (control group and remifentanil group induction of anesthesia will be achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil (1-4 ng/mL) by TCI target controlled infusion, and desflurane . Throughout the surgery hemodynamic parameters are going to be recorded. As soon as the surgery has been finished, in control group remifentanil infusion and desflurane inhalation is going to be stopped.In remifentanil group,desflurane inhalation is going to be stopped and remifentanil infusion will be maintained until the removal of LMA. During the emergence period the time of eye opening, hemodynamic parameters and emergence quality (score 1-2)are going to be recorded.
Interventions
DRUGremifentanil
1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.
Sponsors
Diskapi Teaching and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* ASA I-II status * aged 18-60 years old * presenting for ureterorenoscopy
Exclusion criteria
* history of hypertension * asthma and chronic obstructive lung disease * recent respiratory tract infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smooth cLMA Removal Condition (Score 1) | At the end of the surgery | cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2) |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ultiva,Remifentanil,Opioid,Analgesic Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery | 21 |
| Control Control:Remifentanil stopped at the end of the surgery | 20 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | the failure while performing URS | 0 | 1 |
Baseline characteristics
| Characteristic | Control | Ultiva,Remifentanil,Opioid,Analgesic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 21 Participants | 41 Participants |
| Age Continuous | 38 years STANDARD_DEVIATION 12 | 41 years STANDARD_DEVIATION 13 | 39 years STANDARD_DEVIATION 12 |
| Region of Enrollment Turkey | 20 participants | 21 participants | 41 participants |
| Sex: Female, Male Female | 6 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 14 Participants | 19 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Smooth cLMA Removal Condition (Score 1)
cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)
Time frame: At the end of the surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remifentanil Group | Smooth cLMA Removal Condition (Score 1) | 86 percentage of participants |
| Control Group | Smooth cLMA Removal Condition (Score 1) | 40 percentage of participants |
Comparison: The incidence of complications on removal of the cLMA has been reported 54 % in awake patients group A power analysis indicated that a minimum 16 patients in each group were required to demonstrate a difference that 50% reduction the complications (a power of 80% and α error 0.05).p-value: <0.05Chi-squared