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Hydromorphone as an adjuvant induction agent in reducing rocuronium induced pain and hemodynamic changes during tracheal intubation

Comparison of pretreatment with hydromorphone and fentanyl as an adjuvant induction agent in adult Korean surgical patients: the effect on rocuronium induced pain and hemodynamic change during tracheal intubation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000316000
Enrollment
60
Registered
2010-04-20
Start date
2008-08-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Attenuation of rocuronium-induced withdrawal movements with opioids pretreatment may be attributed to peripheral anti-nociception at the veins. Hydromorphone, known to have a delayed systemic analgesic onset time of five minutes, may present immediate analgesia to rocuronium injection pain via peripheral effects. We compared the effects of a pretreatment with hydromorphone in reducing rocuronium-induced withdrawal movements and hemodynamic changes during tracheal intubation to those of fentanyl and normal saline. One hundred and ninety four patients were randomly assigned to receive 5 ml of hydromorphone 2 mg or fentanyl 100 µg or normal saline. Thirty seconds after administering the study drug, anaesthesia was induced with 2.5% thiopental sodium 5 mg/kg. After the loss of consciousness, rocuronium 0.6 mg/kg was injected, and immediate withdrawal movements were recorded. Two minutes after rocuronium injection, the tracheal intubation was performed and the hemodynamic changes were observed. A total of 190 patients were analyzed and the overall incidence of withdrawal movements was significantly lower in the hydromorphone (2 patients; 3%) and fentanyl group (5 patients; 7.9%) than in saline group (36 patients; 59%) (P < 0.001). The MAP (mean arterial pressure) and HR (heart rate) after intubation in hydromorphone and fentanyl group were significantly lower than those in saline group (fentanyl group P = 0.003, < 0.001; hydromorphone group P < 0.001, < 0.001 respectively). Hydromorphone conveyed immediate substantial analgesia to rocuronium pain-induced withdrawal movement comparable to fentanyl effect and also reduced the hemodynamic responses to tracheal intubation.

Interventions

Groups are divided according to the pretreatment drugs : (a)hydromorphone (hydromorphone group), (b) fentanyl (fentanyl group) or (c) normal saline (normal saline group) During preoxygenation with 100% oxygen, the study drug was injected over 30 sec and an investigator blinded to the study drug observed the signs of side effects, such as apnea or coughing, for 30 sec. The study drugs were 5 ml of either intravenous (IV) hydromorphone hydrochloride 2 mg (Dilid registered trademark, Ha Na Phram,

Groups are divided according to the pretreatment drugs : (a)hydromorphone (hydromorphone group), (b) fentanyl (fentanyl group) or (c) normal saline (normal saline group) During preoxygenation with 100% oxygen, the study drug was injected over 30 sec and an investigator blinded to the study drug observed the signs of side effects, such as apnea or coughing, for 30 sec. The study drugs were 5 ml of either intravenous (IV) hydromorphone hydrochloride 2 mg (Dilid registered trademark, Ha Na Phram, Seoul, Korea; hydromorphone group, n = 65) or intravenous (IV) fentanyl citrate 100 microgram (Gu Ju Pharm, Seoul, Korea; fentanyl group, n = 67) or intravenous (IV) normal saline (sodium chloride, Joong Wae Pharm, Seoul, Korea; saline group, n = 62).Then 2.5% thiopental sodium 5 mg/kg was injected over 5 sec. After the loss of consciousness and eyelash reflexes, when the appropriate end tidal carbon dioxide curve appeared on capnography upon trial of mask ventilation with the fraction of oxygen ratio (FiO2) 1.0, rocuronium 0.6 mg/kg was injected over 5 sec. The time interval between the study drug injection and rocuronium injection was set to be < 90 sec in all patients. Two anesthesiologists, one who administered the study drug and another to conduct the anesthetic induction, assessed the patient response during and immediately after rocuronium injection in a double-blinded manner. The two investigators were educated beforehand to grade the patient response according to the scale proposed by Shevchenko and colleagues 12: 1 = no movement, 2 = movement at the wrist only, 3 = movement/withdrawal involving the arm only (elbow/shoulder), 4 = generalized response, withdrawal or movement in more than one extremity. Sevoflurane was started after the rocuronium injection and was adjusted to maintain an end-tidal concentration of 2.5-3.0 vol% in 100% oxygen. Two minutes after the rocuronium injection, the anesthesiologist who had more than 4 years’ experience of anesthetic practice performed tracheal intubation and applied controlled ventilation in order to maintain normocarbia without ballooning the cuff for 1 min to avoid stimulation. The patient movement and the status of vocal cord relaxation were observed during tracheal intubation. Anaesthesia was maintained with sevoflurane (end-tidal concentration of 2-3 vol%). The time interval between the study drug injection and intubation was designed to be within three to four minutes in all patients. The intubation time, which was defined as the time from mouth opening to obtaining the appropriate capnographic trace, was measured in all patients. The mean arterial pressure and heart rate were measured upon arrival at the operating room, 1 min before and after tracheal intubation. If there was an increase of heart rate (> 40% in baseline) and/or increased blood pressure with ST change in electrocardiogram after intubation, the administration of IV esmolol (0.3 mg/kg) was available.

Sponsors

Chul Joong Lee, M.D., Ph.D.
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Ages between 20-70 yr, American Society of Anesthesia (ASA) physical status I or II and undergoing general anesthesia for elective gastric and colorectal surgery from August 2008 to January 2009

Exclusion criteria

Known allergy to opioids, diabetes mellitus, asthma, neurological deficit, pregnancy or patients who had received analgesics or sedatives within the previous 24 h

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026