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Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment

Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01277861
Enrollment
100
Registered
2011-01-17
Start date
2011-01-31
Completion date
2011-06-30
Last updated
2013-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Administration Site Reaction

Keywords

Desflurane, Fentanyl, Airway responses

Brief summary

The investigators plan to test the hypothesis that pretreatment with fentanyl prior to induction of anesthesia would result in reduce the incidence of movements and airway responses to desflurane in patients breathing spontaneously through a laryngeal mask airway (LMA). The primary aim of this study is to assess the effect of fentanyl pretreatment on the incidence of movement during induction of anesthesia. Secondary aim of the study is to evaluate the effects of titration of fentanyl according to the respiratory rate on the incidence of intraoperative respiratory events such as coughing, breath holding and laryngospasm.

Detailed description

After obtaining approval from the institutional review board and informed consent, 100 patients, 18-64 years of age, scheduled for elective superficial and peripheral surgery of less than 2 h duration would be enrolled in this prospective, randomized, double-blind, placebo-controlled study. Patients will be randomly assigned to one of two anesthetic techniques according to a computer-generated random numbers table. Patients will receive either fentanyl or saline prior to induction of anesthesia, while the rest of the anesthetic and analgesic technique will be standardized for all patients. Exclusion criteria will include obesity (body mass index \>30), pregnancy, history of gastroesophageal reflux, hiatal hernia, significant cardiovascular, pulmonary (e.g., reactive airway disease), hepatic, renal, neurologic, metabolic, and endocrine disease as well as history of alcohol and drug abuse as well as those requiring tracheal intubation. After premedication with midazolam 2 mg, patients will be transferred to the operating room. On arrival in the operating room standard monitors and the BIS (BiSpectral Index)monitor will be applied. Patients will then be preoxygenated for 2-3 minutes with 100% oxygen, which will be followed by administration of either fentanyl 1 µg/kg (made up to 10 ml saline) or 10 ml saline (prepared by a person not involved in the study). Induction of anesthesia will be performed 2-3 minutes after administration of the study drug with propofol 2.0 - 2.5 mg/kg after lidocaine 2% 20-30 mg. After loss of eyelash reflex an appropriate size LMA will be placed. If the patients become apneic, manual ventilation will be performed with oxygen/nitrous oxide and desflurane, 3% dialed concentration initially and then titrated to maintain the BIS value of 50-60. Anesthesia will be maintained with desflurane titrated to achieve a BIS value of 50-60, along with 50% nitrous oxide and oxygen. Once spontaneous breathing resumes, fentanyl 25-50 µg will be administered to achieve a respiratory rate of 10-15 breaths/minute. Additional propofol/fentanyl will be administered, if deemed necessary by the attending anesthesiologist. All patients will receive dexamethasone 4 mg, IV after induction of anesthesia and ondansetron 4 mg 20-30 minutes prior to the end of surgery. Desflurane will be discontinued after closure of the surgical wound. A blinded observer will record patient demographics (age, weight, height) and history of smoking from preoperative evaluation. Data collected during the intraoperative period will include need for manual ventilation and duration of manual ventilation, duration of anesthesia, total doses of propofol and fentanyl, and time from discontinuation of desflurane until patient first follows verbal command as well as heart rate (HR), mean arterial blood pressure (MAP), end-tidal carbon dioxide, oxygen saturation, and end-tidal gas concentration will be recorded every 15 minutes. Data collected in the postoperative period will include verbal rating score (0 to 10) will be used to assess pain, nausea, and vomiting in the recovery room every 15 minutes for one hour as well as the need for rescue medications will also be recorded. Patients will also be contacted approximately 24 hours after surgery to evaluate their post operative course including occurrence of any adverse events. The patient will remain in the study for approximately 24 hours.

Interventions

DRUGFentanyl

FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA

Sponsors

Baxter Healthcare Corporation
CollaboratorINDUSTRY
University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* 18-64 years of age * Subjects scheduled for elective superficial and peripheral surgery of less than 2 h duration (e.g., hernia surgery, breast surgery, upper or lower limb surgery, superficial abdominal/chest wall surgery \[i.e., lipoma\], minor gynecological procedures \[i.e., hysteroscopy\])

Exclusion criteria

* obesity (body mass index \>30) * pregnancy * history of gastroesophageal reflux, hiatal hernia, significant cardiovascular, pulmonary (e.g., reactive airway disease), hepatic, renal, neurologic, metabolic, and endocrine disease * history of alcohol and drug abuse * requiring tracheal intubation.

Design outcomes

Primary

MeasureTime frameDescription
MovementInduction of AnesthesiaThe data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).

Secondary

MeasureTime frameDescription
ApneaInduction of AnesthesiaApnea defined as no breathing for at least 30 s.
CoughingIntraoperative periodData include patients who coughed irrespective of the degree of coughing.

Countries

United States

Participant flow

Recruitment details

Patients were recruited for the study in the preoperative period.

Pre-assignment details

Participants were included based on inclusion/exclusion criteria. Participants were excluded if muscle relaxation was necessary for the surgery.

Participants by arm

ArmCount
FENTANYL
FENTANYL
49
SALINE
SALINE
47
Total96

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision22

Baseline characteristics

CharacteristicFENTANYLSALINETotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
49 Participants47 Participants96 Participants
Body Mass Index26.8 kg/m2
STANDARD_DEVIATION 4.3
26.8 kg/m2
STANDARD_DEVIATION 4.7
26.8 kg/m2
STANDARD_DEVIATION 4.5
Sex: Female, Male
Female
25 Participants25 Participants50 Participants
Sex: Female, Male
Male
24 Participants22 Participants46 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 490 / 47
serious
Total, serious adverse events
0 / 490 / 47

Outcome results

Primary

Movement

The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).

Time frame: Induction of Anesthesia

Population: Per protocol

ArmMeasureValue (NUMBER)
Fentanyl Pretreatment GroupMovement8 Participants, number
Saline Pretreatment GroupMovement24 Participants, number
Secondary

Apnea

Apnea defined as no breathing for at least 30 s.

Time frame: Induction of Anesthesia

Population: Per protocol

ArmMeasureValue (NUMBER)
Fentanyl Pretreatment GroupApnea46 Participants, number
Saline Pretreatment GroupApnea30 Participants, number
Secondary

Coughing

Data include patients who coughed irrespective of the degree of coughing.

Time frame: Intraoperative period

Population: Per protocol

ArmMeasureValue (NUMBER)
Fentanyl Pretreatment GroupCoughing1 Participants, number
Saline Pretreatment GroupCoughing6 Participants, number

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026