The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
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ClinicalTrials.gov Identifier: NCT01532466 |
Recruitment Status :
Completed
First Posted : February 14, 2012
Last Update Posted : February 14, 2012
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Condition or disease | Intervention/treatment | Phase |
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Fentanyl-induced Coughing | Drug: Rocuronium | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 260 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Prevention |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | November 2011 |
Arm | Intervention/treatment |
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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).
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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).
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- Incidence of fentanyl-induced coughing [ Time Frame: 2 minutes ]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%).

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532466
Taiwan | |
Taichung Armed Forces General Hospital | |
Taichung, Taiwan, 411 |
Study Director: | Chih-Shung Wong, PhD | Cathay General Hospital |
Responsible Party: | Huei-Chi Horng, MD, Principal Investigator, Taichung Armed Forces General Hospital |
ClinicalTrials.gov Identifier: | NCT01532466 |
Other Study ID Numbers: |
TC100-5 |
First Posted: | February 14, 2012 Key Record Dates |
Last Update Posted: | February 14, 2012 |
Last Verified: | December 2011 |
fentanyl-induced coughing, rocuronium |
Cough Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Rocuronium |
Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs |