An interventional study of Normal saline and Remifentanil in Pain and Anesthesia, sponsored by Tianjin Medical University General Hospital. Completed at 1 site in China. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-08-03.
Sponsored by Tianjin Medical University General Hospital · Not applicable, Interventional, and Prevention
To explore and compare antihyperalgesic effects of Dexmedetomidine,Nalmefene,and a combination of both received before anesthesia induction.
To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.
There are a dramatically increasing number of evidences that administration of the potent, ultra-short-acting opioid remifentanil seems to cause opioid-induced hyperalgesia (OIH) more frequently and predictably compared with the others, likely due to its rapid onset and offset. Therefore, prophylaxis of remifentanil induced hyperalgesia is indispensable to postoperative comfort and satisfaction.
There is no denying the fact that OIH is related to central glutaminergic system and N-methyl-d-aspartate(NMDA)receptor-activation induced central sensitization. Dexmedetomidine is an 2-adrenergic agonist that has been shown to synergize with opioids. Dexmedetomidine inhibits NMDAR excitability by reducing the phosphorylation of N-methyl-D-aspartate receptor 2B subunit phosphorylation of spinal dorsal horn induced by remifentanil, thereby achieving the goal of reducing OIH. Nalmefene is a pure opioid receptor antagonist that antagonizes the Mu receptor, alleviating the central sensitization of NMDA, thereby reducing OIH. At the same time reported in the literature, opioid receptor has a bimode：On the one hand can be mediated by Gs protein-mediated pain, respiratory depression, nausea and vomiting, etc ; on the other hand can be coupled with Gi / Go protein mediated analgesic effect. Low-dose nalmefene (\<1.0ug / kg) and other opioid receptor antagonists can antagonize the role of Gs protein-coupled opioid receptors, blocking the pathway of opioid excitatory effects, thereby reducing the incidence of adverse reactions.The following study is carried out to evaluate whether dexmedetomidine combined with nalmefene can be safely and effectively applied to prevent postoperative hyperalgesia induced by remifentanil in patients undergoing Laparoscopic gynecological surgery.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 150 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Tianjin Medical University General Hospital is the lead sponsor of 75 studies on the registry; 31 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
Drug: Normal saline · Drug: Remifentanil
Normal saline is intravenously admistrated before anesthesia induction and intraoperative pain management was with sufentanil
Drug: Normal saline · Drug: Sufentanil
Dexmedetomidine is intravenously administrated at a dose of 0.5ug/kg 10min before anesthesia induction and intraoperative pain management was with remifentanil
Drug: Remifentanil · Drug: Dexmedetomidine injection
Nalmefene is intravenously administrated at a dose of 0.2ug/kg before anesthesia induction and intraoperative pain management was with remifentanil
Drug: Remifentanil · Drug: Nalmefene
A dose of 0.1ug/kg nalmefene and a dose of 0.25ug/kg dexmedetomidine for 10 minutes before anesthesia induction and intraoperative pain management was with remifentanil
Drug: Remifentanil · Drug: Dexmedetomidine injection · Drug: Nalmefene
Normal saline is intravenously administrated before anesthesia induction
Also known as: 0. 9% Sodium Chloride Injection
Remifentanil is intravenously administrated
Also known as: Remifentanil Hydrochloride for Injection
Sufentanil is intravenously administrated
Also known as: Sufentanil injection
Dexmedetomidine is intravenously administrated before anesthesia induction
Also known as: Dexmedetomidine
Nalmefene is intravenously administrated before anesthesia induction
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 at 24 hours postoperatively
Time frame: 24 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.
Time frame: 1hours,3hours，6hours，12hours，24hours after surgery
Pain Score (Numerical Rating Scale)
The pain score at rest was evaluated by pain 11-point numerical rating scale : 0 = no pain, 10 = greatest imaginable pain.
Time frame: 1hours,3hours，6hours，12hours，24hours after surgery
Time of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
Time frame: postoperative 1 hours
Cumulative Sufentanyl Consumption
Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving post-anaesthesia 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. Sufentanyl cumulative consumption is recorded 24 hours postoperatively
Time frame: 1hours,3hours，6hours，12hours，24hours after surgery
Occurrence of Side Effects
Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus，hypotention/hypertention，bradycardia/tachycardia
Time frame: 24 hours
From February 2017 to September 2017, patients were recruited and estimated for eligibility
| Milestone | Normal Saline | Sufentanil | Dexmedetomidine | Nalmefene | Dexmedetomidine-Nalmefene |
|---|---|---|---|---|---|
| Started | 30 | 30 | 30 | 30 | 30 |
| Completed | 27 | 27 | 27 | 27 | 27 |
| Not completed | 3 | 3 | 3 | 3 | 3 |
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 at 24 hours postoperatively
| g | Normal Saline | Sufentanil | Dexmedetomidine | Nalmefene | Dexmedetomidine-Nalmefene |
|---|---|---|---|---|---|
| Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm | 61.5 ± 6.0 | 88.2 ± 23.40 | 73.0 ± 3.2 | 67.2 ± 3.3 | 74.0 ± 9.3 |
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.
Results for this outcome have not been posted.
The pain score at rest was evaluated by pain 11-point numerical rating scale : 0 = no pain, 10 = greatest imaginable pain.
Results for this outcome have not been posted.
First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
Results for this outcome have not been posted.
Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving post-anaesthesia 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. Sufentanyl cumulative consumption is recorded 24 hours postoperatively
Results for this outcome have not been posted.
Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus，hypotention/hypertention，bradycardia/tachycardia
Results for this outcome have not been posted.
Collected over Incidence of adverse effects was evaluated during 24h after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Normal Saline | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Sufentanil | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Dexmedetomidine | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Nalmefene | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Dexmedetomidine-Nalmefene | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Age, Continuous(years) | Normal Saline | Sufentanil | Dexmedetomidine | Nalmefene | Dexmedetomidine-Nalmefene | Total |
|---|---|---|---|---|---|---|
| Mean | 47.0 ± 5.0 | 46.0 ± 8.0 | 45.0 ± 12 | 47.0 ± 10 | 46.0 ± 9 | 46.2 ± 8.8 |
| Sex: Female, Male(Participants) | Normal Saline | Sufentanil | Dexmedetomidine | Nalmefene | Dexmedetomidine-Nalmefene | Total |
|---|---|---|---|---|---|---|
| Female | 27 | 27 | 27 | 27 | 27 | 135 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Normal Saline | Sufentanil | Dexmedetomidine | Nalmefene | Dexmedetomidine-Nalmefene | Total |
|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | 0 |
| Region of Enrollment(participants) | Normal Saline | Sufentanil | Dexmedetomidine | Nalmefene | Dexmedetomidine-Nalmefene | Total |
|---|---|---|---|---|---|---|
| China | 27 | 27 | 27 | 27 | 27 | 135 |
| Weight(Kg) | Normal Saline | Sufentanil | Dexmedetomidine | Nalmefene | Dexmedetomidine-Nalmefene | Total |
|---|---|---|---|---|---|---|
| Mean | 60 ± 7 | 57 ± 8 | 59 ± 7 | 58 ± 5 | 60 ± 8 | 59 ± 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — data not entered
Ran from Feb 2017 to primary completion in Dec 2017, 10 months.
Results were first posted in Aug 2021, 3 years 7 months after primary completion.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 10 months is close to that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexmedetomidine · Nalmefene
Tianjin Medical University General Hospital