Clinical trial NCT04547608: Timing of Rocuronium After Induction With Propofol on Temporal Summation of Pain
Official title: The Impact of the Timing of Rocuronium After Induction With Propofol on Temporal Summation of Pain in Gynecologic Laparoscopic Surgery-prospective and Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecological Disorder
Keywords: Pain, Propofol, Rocuronium, Temporal summation.
Lead sponsor: Wonkwang University Hospital
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One hundred patients, between 18-60 years of age were randomly assigned to one of the two groups; group PRi received immediate injection of rocuronium after propofol administration, and group PRd received rocuronium injection when bispectral index score became below 60 after propofol administration
Primary purpose: PREVENTION

Brief summary: Temporal summation of pain, which is defined as the perception of increasingly greater pain evoked by repetitive painful stimuli, is highly variable between individuals. This study aimed to determine the impact of the timing of rocuronium after induction with propofol on temporal summation of pain in gynecologic laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Elective gynecologic laparoscopic surgery
* American Society of Anesthesiologists' physical status class) I-II

Exclusion Criteria:

* Menopause (to exclude the hormonal effect on pain)
* Patients who had muscular, cardiovascular, hepatic or kidney disorders and patients with a history of medication who would affect muscle relaxants were excluded from this study.
* Patients with difficult venous access on forearm, a known allergy to propofol or rocuronium, chronic pain, pregnancy, and those who had received analgesics or sedatives within the previous 24 hours, were excluded from the study.

Primary outcomes:
measure: the grade of rocuronium induced withdrawal movement.
timeFrame: during anesthesia induction
Secondary outcomes:
measure: visual analog scale (VAS) for injection pain
timeFrame: during anesthesia induction
measure: VAS for pain
timeFrame: at 1 hour, 24 hours and 48 hours
measure: Patient controlled analgesia (PCA) Opioid consumption
timeFrame: at 24 and 48 hours
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: WonwangUH
state: Jeonbuk
Study officials:
affiliation: Department of anesthesiology and pain medicine
name: Cheol Lee, M.D,Ph.D
role: STUDY_DIRECTOR
References:
citation: Cheng JC, Erpelding N, Kucyi A, DeSouza DD, Davis KD. Individual Differences in Temporal Summation of Pain Reflect Pronociceptive and Antinociceptive Brain Structure and Function. J Neurosci. 2015 Jul 1;35(26):9689-700. doi: 10.1523/JNEUROSCI.5039-14.2015.
citation: Ayoglu H, Altunkaya H, Ozer Y, Yapakci O, Cukdar G, Ozkocak I. Does dexmedetomidine reduce the injection pain due to propofol and rocuronium? Eur J Anaesthesiol. 2007 Jun;24(6):541-5. doi: 10.1017/S0265021506002250. Epub 2007 Jan 23.
citation: Hwang SM, Cho SH, Lim SY, et al. The efficacy of BIS monitoring for the preventing of withdrawal movement on the intravenous injection of rocuronium. Korean J Anesthesiol 2005;49:293-7.
citation: Lim BG, Lee IO, Kim YS, Won YJ, Kim H, Kong MH. The utility of bispectral index monitoring for prevention of rocuronium-induced withdrawal movement in children: A randomized controlled trial. Medicine (Baltimore). 2017 Jan;96(2):e5871. doi: 10.1097/MD.0000000000005871.