Gynecological DisorderNCT04547608
Timing of Rocuronium After Induction With Propofol on Temporal Summation of Pain
A study testing The difference of the timing of rocuronium administration after propofol injection in people with Gynecological Disorder, run by Wonkwang University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological Disorder
- What is being tested?
- The difference of the timing of rocuronium administration after propofol injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2020to 4 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective gynecologic laparoscopic surgery
- American Society of Anesthesiologists' physical status class) I-II
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Gynecological Disorder
- Being tested
- The difference of the timing of rocuronium administration after propofol injection
- Keywords
- Pain, Propofol, Rocuronium, Temporal summation.
- Medical subject headings
- Genital Diseases, Female, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The difference of the timing of rocuronium administration after propofol injectionOther
The difference of the timing was rocuronium was administered immediately after propofol injection or when BIS score became below 60 after propofol administration.
| Study group | Role | What they receive |
|---|---|---|
| group PRi | Other | received immediate injection of rocuronium after propofol administration, Receives: Other: The difference of the timing of rocuronium administration after propofol injection |
| group PRd | Other | rocuronium injection when bispectral index score became below 60 after propofol administration Receives: Other: The difference of the timing of rocuronium administration after propofol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during anesthesia induction
Secondary outcomes (3)
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
Measured: during anesthesia induction
VAS for pain
check VAS with 100 mm for pain after surgery. 0 = no pain, 100 = the worst pain
Measured: 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.
Measured: at 24 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 May 2020
- Primary completion30 May 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gynecological DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Lee, Wonkwang University Hospital
- Investigators
- Cheol Lee, M.D,Ph.D, Study director, Department of anesthesiology and pain medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547608
- Sponsor's protocol ID
- WonkwangUH7
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26134651Ayoglu 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.
PubMed 17241503Hwang 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.
PubMed 28079825
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04547608
- Acronym / sponsor ID
- WonkwangUH7
- Conditions
- Gynecological Disorder
- Keywords
- Pain, Propofol, Rocuronium, Temporal summation.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| group PRi | Other | Other: The difference of the timing of rocuronium administration after propofol injectionreceived immediate injection of rocuronium after propofol administration, |
| group PRd | Other | Other: The difference of the timing of rocuronium administration after propofol injectionrocuronium injection when bispectral index score became below 60 after propofol administration |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Elective gynecologic laparoscopic surgery
- American Society of Anesthesiologists' physical status class) I-II
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The difference of the timing of rocuronium administration after propofol injectionThe 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, group PRi |
Primary outcome
the grade of rocuronium induced withdrawal movement.
Time frame: during anesthesia induction
withdrawal movements were graded by the investigator according to the following scale: 1. - no pain (no response); 2. - mild pain (movement at wrist only); 3. - moderate pain (movement involving the arm only with elbow or shoulder); 4. - severe pain (generalized response or movement in more than one extremity
3 secondary outcomes
visual analog scale (VAS) for injection pain
Time frame: during anesthesia induction
VAS for pain
Time frame: at 1 hour, 24 hours and 48 hours
Patient controlled analgesia (PCA) Opioid consumption
Time frame: at 24 and 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 26134651Cheng 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.
- Background: PubMed 17241503Ayoglu 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.
- BackgroundHwang 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.
- Background: PubMed 28079825Lim 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.
- Individual participant dataSharing planned: No
Related trials for Gynecological Disorder
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
Healthy Adult Participants, Gynecological Disease
RecruitingObservational study
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GYN Disorders
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheol Lee, M.D,Ph.D study director
Department of anesthesiology and pain medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The difference of the timing of rocuronium administration after propofol injection in people with Gynecological Disorder, run by Wonkwang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the grade of rocuronium induced withdrawal movement. (time frame: during anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04547608, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.