Timing of Rocuronium After Induction With Propofol on Temporal Summation of Pain

The Impact of the Timing of Rocuronium After Induction With Propofol on Temporal Summation of Pain in Gynecologic Laparoscopic Surgery-prospective and Controlled Study.

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.

Study Overview

• Status: Completed
• Conditions: Gynecological Disorder
• Intervention / Treatment: Other: The difference of the timing of rocuronium administration after propofol injection

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonbuk
    • Iksan, Jeonbuk, Korea, Republic of, 570-711
      • WonwangUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group PRi; received immediate injection of rocuronium after propofol administration,	Other: The difference of the timing of rocuronium administration after propofol injection; The difference of the timing was rocuronium was administered immediately after propofol injection or when BIS score became below 60 after propofol administration.
Other: group PRd; rocuronium injection when bispectral index score became below 60 after propofol administration	Other: The difference of the timing of rocuronium administration after propofol injection; The difference of the timing was rocuronium was administered immediately after propofol injection or when BIS score became below 60 after propofol administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the grade of rocuronium induced withdrawal movement.	withdrawal movements were graded by the investigator according to the following scale: - no pain (no response);; - mild pain (movement at wrist only);; - moderate pain (movement involving the arm only with elbow or shoulder);; - severe pain (generalized response or movement in more than one extremity	during anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale (VAS) for injection pain	check VAS for pain after propofol administration. visual analog scale with 100 mm for pain after surgery. 0 = no pain, 100 = the worst pain	during anesthesia induction
VAS for pain	check VAS with 100 mm for pain after surgery. 0 = no pain, 100 = the worst pain	at 1 hour, 24 hours and 48 hours
Patient controlled analgesia (PCA) Opioid consumption	check the volume of PCA Opioid consumption (ml) (PCA) pump containing fentanyl (800 ug), ketorolac (150 mg), and ramosetron (0.6 mg) in a total volume of 150 mL of saline was set to deliver a basal infusion of 2 mL/h and bolus doses of 0.5 mL, with a 15-min lockout period for postoperative analgesia.	at 24 and 48 hours

Collaborators and Investigators

• Sponsor: Wonkwang University Hospital
• Investigators: Study Director: Cheol Lee, M.D,Ph.D, Department of anesthesiology and pain medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): September 4, 2020

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Pain, Propofol, Rocuronium, Temporal summation.
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Propofol; Rocuronium
• Other Study ID Numbers: WonkwangUH7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No