Inflammatory ResponseNCT04630938
Effects of Anaesthesia on Inflammatory Markers
A study testing Morphine Sulfate, morphine+lidocaine and Saline in people with Inflammatory Response, run by Assiut University at 1 site in Egypt.
Trial summary
undertake confidently both open and laparoscopic cholecystectomy. Major types of body injuries surgical or accidental; evoke a temporary, yet predictable systemic inflammatory response caused by hormonal, immunological and metabolic mediators. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- Morphine Sulfate, morphine+lidocaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Oct 2020to 30 Oct 2021
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aging 18 - 55 years old
- Patients scheduled for abdominal surgeries
- Patients with American Society of Anesthesiologists (ASA) I, II physical status
Who cannot join
- Patients' refusal.
- Critically ill patients.
- Patients who have contraindications to regional anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Anesthetics on Inflammatory Markers in Patients Undergoing Abdominal Surgeries.
undertake confidently both open and laparoscopic cholecystectomy. Major types of body injuries surgical or accidental; evoke a temporary, yet predictable systemic inflammatory response caused by hormonal, immunological and metabolic mediators. This inflammatory response is essential for tissue repair and has evolved to maximize the organisms' healing potential. In healthy individuals the inflammatory response to major surgery is well balanced consisting of pro- and anti-inflammatory mediators. The severity of injury, the occurrence of surgical complications and its accompanying level of stress may hinder the balance of the inflammatory response6.
- Conditions
- Inflammatory Response
- Being tested
- Morphine Sulfate, morphine+lidocaine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
intrathecal morphine will be added to anaesthetics
morphine+lidocaineDrug
local anesthetic will be infused intravenously
SalineDrug
intravenous saline infusion
| Study group | Role | What they receive |
|---|---|---|
| G-M | Active comparator | Received classic general Anesthesia, intrathecal (Bupivacaine 15 mg, morphine 4 microgram/kg) plus saline infusion intraoperative and postoperative. Receives: Drug: Morphine Sulfate |
| G-ML | Active comparator | Received classic general Anesthesia, intrathecal morphine in a dose of 4 microgram/kg, and intravenous lidocaine in a loading dose of 1.5 mg/kg, then 2 mg/min with the saline infusion over the time of the operation and the next 4 hours postoperative. Receives: Drug: morphine+lidocaine |
| G-0 | Placebo comparator | Received General Anesthesia and Spinal anesthesia as previously described with saline infusion in the same design as in the previous two groups. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
a scale to measure pain intensity graded from 0 = no pain to 10 = worst pain
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start24 Oct 2020
- Primary completion1 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esam Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630938
- Sponsor's protocol ID
- 17300478
- Status last verified
- Feb 2022
- First submitted
- 12 Jul 2020
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anesthetics on Inflammatory Markers in Patients Undergoing Abdominal Surgeries.
- ClinicalTrials.gov ID
- NCT04630938
- Acronym / sponsor ID
- 17300478
- Conditions
- Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 16 Nov 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.
undertake confidently both open and laparoscopic cholecystectomy. Major types of body injuries surgical or accidental; evoke a temporary, yet predictable systemic inflammatory response caused by hormonal, immunological and metabolic mediators. This inflammatory response is essential for tissue repair and has evolved to maximize the organisms' healing potential. In healthy individuals the inflammatory response to major surgery is well balanced consisting of pro- and anti-inflammatory mediators. The severity of injury, the occurrence of surgical complications and its accompanying level of stress may hinder the balance of the inflammatory response6.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G-M | Active comparator | Drug: Morphine SulfateReceived classic general Anesthesia, intrathecal (Bupivacaine 15 mg, morphine 4 microgram/kg) plus saline infusion intraoperative and postoperative. |
| G-ML | Active comparator | Drug: morphine+lidocaineReceived classic general Anesthesia, intrathecal morphine in a dose of 4 microgram/kg, and intravenous lidocaine in a loading dose of 1.5 mg/kg, then 2 mg/min with the saline infusion over the time of the operation and the next 4 hours postoperative. |
| G-0 | Placebo comparator | Drug: SalineReceived General Anesthesia and Spinal anesthesia as previously described with saline infusion in the same design as in the previous two groups. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients aging 18 - 55 years old
- Patients scheduled for abdominal surgeries
- Patients with American Society of Anesthesiologists (ASA) I, II physical status
Key exclusion criteria (3 listed)
- Patients' refusal.
- Critically ill patients.
- Patients who have contraindications to regional anesthesia.
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 |
|---|---|---|
| Morphine Sulfateintrathecal morphine will be added to anaesthetics | Drug | G-M |
| morphine+lidocainelocal anesthetic will be infused intravenously | Drug | G-ML |
| Salineintravenous saline infusion | Drug | G-0 |
Primary outcome
Visual analogue score
Time frame: 24 hours
a scale to measure pain intensity graded from 0 = no pain to 10 = worst pain
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 24 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine Sulfate, morphine+lidocaine and Saline in people with Inflammatory Response, run by Assiut University at 1 site in Egypt.
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 3 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 24 Feb 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Visual analogue score (time frame: 24 hours). 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 24 Feb 2022.