The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
This study has been completed.
Sponsor:
Taichung Armed Forces General Hospital
Information provided by (Responsible Party):
Huei-Chi Horng, MD, Taichung Armed Forces General Hospital
ClinicalTrials.gov Identifier:
NCT01532466
First received: February 7, 2012
Last updated: February 9, 2012
Last verified: December 2011
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Purpose
An intravenous bolus of fentanyl often induces a cough reflex. This study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.
| Condition | Intervention |
|---|---|
|
Fentanyl-induced Coughing |
Drug: Rocuronium |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
Resource links provided by NLM:
Further study details as provided by Taichung Armed Forces General Hospital:
Primary Outcome Measures:
- Incidence of fentanyl-induced coughing [ Time Frame: 2 minutes ] [ Designated as safety issue: Yes ]Following the fentanyl injection, another anesthetist who was blind to the pretreatment recorded the number of coughs for 1 min. The severity of coughing was graded as mild (1-2 times), moderate (3-5 times), or severe (> 5 times) based on the number of coughs within the 1 min following the fentanyl injection. Assisted mask ventilation with oxygen was supplied if desaturation occurred (SpO2 < 90%).
| Enrollment: | 260 |
| Study Start Date: | March 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rocuronium, fentanyl-induced cough, normal saline
All patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the rocuronium group received rocuronium 0.06 mg kg-1 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s).
|
Drug: Rocuronium
All patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the rocuronium group received rocuronium 0.06 mg kg-1, and the control group received the same volume of normal saline 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s).
|
|
No Intervention: Normal saline
All patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the control group received the same volume of normal saline 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s).
|
Detailed Description:
Fentanyl is widely used for analgesia and anesthesia because of its rapid onset, its intense analgesic effect, and is associated with lessened cardiovascular depression and low histamine release. Although the cough reflex is usually transient and self-limiting, it should be avoided in situations such as elevated intracranial, intraocular, or intra-abdominal pressure, and unstable hemodynamics.
The cause of FIC is unclear. One hypothesis is that vocal cord spasms might induce coughing because of fentanyl-induced muscle rigidity and histamine release. Muscle relaxants are commonly used to treat this condition. This study hypothesizes that priming muscle relaxants could prevent or suppress FIC. This study investigates whether the muscle relaxant rocuronium attenuates FIC effectively.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 260 ASA I-II patients,
- aged between 18 and 80 years, and undergoing various elective surgeries at Taichung Armed Forces General Hospital.
Exclusion Criteria:
- a history of asthma,
- chronic cough,
- smoking,
- upper respiratory tract infection in the previous 2 weeks, and
- medication containing angiotensin-converting enzyme inhibitors or anesthetic premedication.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Huei-Chi Horng, MD, Principal Investigator, Taichung Armed Forces General Hospital |
| ClinicalTrials.gov Identifier: | NCT01532466 History of Changes |
| Other Study ID Numbers: | TC100-5 |
| Study First Received: | February 7, 2012 |
| Last Updated: | February 9, 2012 |
| Health Authority: | Taiwan: Department of Health United States: Federal Government |
Keywords provided by Taichung Armed Forces General Hospital:
|
fentanyl-induced coughing, rocuronium |
Additional relevant MeSH terms:
|
Cough Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Fentanyl Rocuronium Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents |
ClinicalTrials.gov processed this record on June 18, 2013