Pain, PostoperativeNCT05028049
Comparison of Remifentanil-induced Postoperative Hyperalgesia Between Patients From Plain Area and Plateau Area
An observational study of Pain, Postoperative and Anesthesia, run by Tianjin Medical University General Hospital at 2 sites in China.
Trial summary
Purpose: 1. To compare the incidence of postoperative hyperalgesia induced by remifentanil in patients undergoing gynecological laparoscopic surgery in plateau and plain areas 2. To compare the peri-operative analgesic requirements of patients in plain and plateau areas Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Pain, Postoperative, Anesthesia
- What is being tested?
- Sufentanil injection, Remifentanil Hydrochloride and plain areas
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 30 Aug 2021to 31 Dec 2021
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients in plateau areas are long staying residents in above 3000 meters above sea level for enrollment, while patients in plain areas are long staying residents below 1000 meters above sea level.
Who may be able to join
- Subject is scheduled to undergo gynecological laparoscopic surgery under a short general anesthesia of less than 2 hours
- Subject's American Society of Anesthesiologists physical status is I-II.
- The subject's parent/legally authorized guardian has given written informed consent to participate.
- Patients in plateau areas are long staying residents in above 3000 meters above sea level for enrollment, while patients in plain areas are long staying residents below 1000 meters above sea level.
Who cannot join
- Subject has a diagnosis of renal or liver failure.
- Subject has a diagnosis of Insulin dependent diabetes.
- Subject is allergy and contraindication to any drugs used during general anesthesia.
- Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
- Subject has any contraindication for the use of patient-controlled analgesia (PCA).
- Subject is pregnant or breast-feeding.
- Subject is obese (body mass index >30kg/m2).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Gannan Tibetan Autonomous Prefecture People's Hospital
Hezuo, Gansu
Yonggang Lv, MD, 86-13512224465, liyizelisa@126.com
Tianjin Medical University General Hospital
Tianjin, 300052
Guolin Wang, +8618604755166
About this study
Official title: Comparison of Remifentanil-induced Postoperative Hyperalgesia After Gynecological Laparoscopic Surgery Between Patients From the Plain Area and the Plateau Area
Purpose:
- To compare the incidence of postoperative hyperalgesia induced by remifentanil in patients undergoing gynecological laparoscopic surgery in plateau and plain areas
- To compare the peri-operative analgesic requirements of patients in plain and plateau areas
Read the detailed description
Our research group has been committed to the research of remifentanil-induced hyperalgesia for a long time. In the previous study, it was found that intraoperative infusion of remifentanil (0.3ug/kg•min) >1h can lead to remifentanil-induced hyperalgesia and the incidence rate is relative high in the plain area. Due to the long-term low pressure and hypoxia of people living in plateau areas, a series of changes will occur in the respiratory and circulatory systems, and their anesthesia management needs to be adjusted accordingly. However, there is no relevant research on whether or not hyperalgesia occurs in people in plateau areas (altitude level >3000 meters). Therefore, this study hopes to compare the incidence and degree of remifentanil-induced hyperalgesia after gynecological laparoscopic surgery in plain areas and plateau areas.
- Conditions
- Pain, Postoperative, Anesthesia
- Being tested
- Sufentanil injection, Remifentanil Hydrochloride, plain areas, plateau areas
- Keywords
- Remifentanil, Opioid-induced hyperalgesia, Postoperative pain, pain intensity
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil injectionDrug
Also called Sufentanil
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia
Remifentanil HydrochlorideDrug
Also called Remifentanil
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia
plain areasOther
Patients should be long staying residents in plain areas (altitude level below 1,000 meters above sea level)
plateau areasOther
Patients should be long staying residents in plateau areas (altitude level>3000 meters above sea level)
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil-analgesia in plain area patients | Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plain area patients. Receives: Drug: Sufentanil injection; Other: plain areas | |
| Remifentanil-analgesia in plain area patients | Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plain area patients. Receives: Drug: Remifentanil Hydrochloride; Other: plain areas | |
| Sufentanil-analgesia in plateau area patients | Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plateau area patients. Receives: Drug: Sufentanil injection; Other: plateau areas | |
| Remifentanil-analgesia in plateau area patients | Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plateau area patients. Receives: Drug: Remifentanil Hydrochloride; Other: plateau areas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament after surgery
Measured: 48 hours after surgery
Secondary outcomes (7)
Pain Score (NRS)
The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10= greatest imaginable pain.
Measured: 48 hours after surgery
Normalized Area of Hyperalgesia Around the Incision
The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.
Measured: 48 hours after surgery
Mechanical hyperalgesia threshold around the incision
The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament.
Measured: 48 hours after surgery
Time of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥5) is initially controlled by titration of Hydromorphone.
Measured: 1 hour after surgery
Total Dose of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥5) is initially controlled by titration of Hydromorphone.
Measured: 1 hour after surgery
Cumulative Hydromorphone Consumption
Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing Hydromorphone (200μg) in normal saline at a total volume of 100 ml after leaving PACU (Postanesthesia care unit). This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Hydromorphone cumulative consumption is recorded 48 hours postoperatively
Measured: 48 hours after surgery
Occurrence of Side Effects
Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start30 Aug 2021 (estimated)
- Primary completion15 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
- Investigators
- Guolin Wang, MD, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028049
- Sponsor's protocol ID
- GWang014
- Status last verified
- Aug 2021
- First submitted
- 21 Aug 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remifentanil-induced Postoperative Hyperalgesia After Gynecological Laparoscopic Surgery Between Patients From the Plain Area and the Plateau Area
- ClinicalTrials.gov ID
- NCT05028049
- Acronym / sponsor ID
- GWang014
- Conditions
- Pain, Postoperative, Anesthesia
- Keywords
- Remifentanil, Opioid-induced hyperalgesia, Postoperative pain, pain intensity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 30 Aug 2021 (estimated)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 31 Aug 2021 (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.
Purpose:
- To compare the incidence of postoperative hyperalgesia induced by remifentanil in patients undergoing gynecological laparoscopic surgery in plateau and plain areas
- To compare the peri-operative analgesic requirements of patients in plain and plateau areas
Detailed description
Our research group has been committed to the research of remifentanil-induced hyperalgesia for a long time. In the previous study, it was found that intraoperative infusion of remifentanil (0.3ug/kg•min) >1h can lead to remifentanil-induced hyperalgesia and the incidence rate is relative high in the plain area. Due to the long-term low pressure and hypoxia of people living in plateau areas, a series of changes will occur in the respiratory and circulatory systems, and their anesthesia management needs to be adjusted accordingly. However, there is no relevant research on whether or not hyperalgesia occurs in people in plateau areas (altitude level >3000 meters). Therefore, this study hopes to compare the incidence and degree of remifentanil-induced hyperalgesia after gynecological laparoscopic surgery in plain areas and plateau areas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sufentanil-analgesia in plain area patients | – | Drug: Sufentanil injection, Other: plain areasSufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plain area patients. |
| Remifentanil-analgesia in plain area patients | – | Drug: Remifentanil Hydrochloride, Other: plain areasRemifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plain area patients. |
| Sufentanil-analgesia in plateau area patients | – | Drug: Sufentanil injection, Other: plateau areasSufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plateau area patients. |
| Remifentanil-analgesia in plateau area patients | – | Drug: Remifentanil Hydrochloride, Other: plateau areasRemifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plateau area patients. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients in plateau areas are long staying residents in above 3000 meters above sea level for enrollment, while patients in plain areas are long staying residents below 1000 meters above sea level.
Key inclusion criteria (4 listed)
- Subject is scheduled to undergo gynecological laparoscopic surgery under a short general anesthesia of less than 2 hours
- Subject's American Society of Anesthesiologists physical status is I-II.
- The subject's parent/legally authorized guardian has given written informed consent to participate.
- Patients in plateau areas are long staying residents in above 3000 meters above sea level for enrollment, while patients in plain areas are long staying residents below 1000 meters above sea level.
Key exclusion criteria (7 listed)
- Subject has a diagnosis of renal or liver failure.
- Subject has a diagnosis of Insulin dependent diabetes.
- Subject is allergy and contraindication to any drugs used during general anesthesia.
- Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
- Subject has any contraindication for the use of patient-controlled analgesia (PCA).
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 |
|---|---|---|
| Sufentanil injectionAlso: SufentanilSufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia | Drug | Sufentanil-analgesia in plain area patients, Sufentanil-analgesia in plateau area patients |
| Remifentanil HydrochlorideAlso: RemifentanilRemifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia | Drug | Remifentanil-analgesia in plain area patients, Remifentanil-analgesia in plateau area patients |
| plain areasPatients should be long staying residents in plain areas (altitude level below 1,000 meters above sea level) | Other | Remifentanil-analgesia in plain area patients, Sufentanil-analgesia in plain area patients |
| plateau areasPatients should be long staying residents in plateau areas (altitude level>3000 meters above sea level) | Other | Remifentanil-analgesia in plateau area patients, Sufentanil-analgesia in plateau area patients |
Primary outcome
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
Time frame: 48 hours after surgery
The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament after surgery
7 secondary outcomes
Pain Score (NRS)
Time frame: 48 hours after surgery
Normalized Area of Hyperalgesia Around the Incision
Time frame: 48 hours after surgery
Mechanical hyperalgesia threshold around the incision
Time frame: 48 hours after surgery
Time of First Postoperative Analgesic Requirement
Time frame: 1 hour after surgery
Total Dose of First Postoperative Analgesic Requirement
Time frame: 1 hour after surgery
Cumulative Hydromorphone Consumption
Time frame: 48 hours after surgery
Occurrence of Side Effects
Time frame: 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Guolin Wang, MD study director
Tianjin Medical University General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Anesthesia, run by Tianjin Medical University General Hospital at 2 sites in China.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guolin Wang, MD (+8618604755166, wangguolinghad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2021.