Abdominal CancerNCT06265948
Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia
An observational study of Abdominal Cancer, run by Assiut University.
Trial summary
( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries ) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Cancer
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to May 2025
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Inclusion Criteria: * a. Inclusion criteria: 1. Age group 18 - 60 years old. 2. Both gender 3. ASA 1and 2 Exclusion Criteria: * a. Inclusion criteria: 1. Age group 18 - 60 years old. 2. Both gender 3. ASA 1and 2 b. Exclusion criteria: <!-- --> 1. Patient refusal, 2. History of cardiac or respiratory disease, psychological disorders, 3. High risk of regurgitation or aspiration based on a history of diabetes, hiatus hernia, gastroesophageal reflux, and obesity, 4. neck pathology, 5. Predicted difficult airway (history of difficult airway, mouth opening
Who may be able to join
- a. Inclusion criteria:
- Age group 18 - 60 years old.
- Both gender
- ASA 1and 2
Who cannot join
- a. Inclusion criteria:
- Age group 18 - 60 years old.
- Both gender
- ASA 1and 2 b. Exclusion criteria:
- <!-- -->
- Patient refusal,
Show all 11Show fewer
- History of cardiac or respiratory disease, psychological disorders,
- High risk of regurgitation or aspiration based on a history of diabetes,
- hiatus hernia, gastroesophageal reflux, and obesity,
- neck pathology,
- Predicted difficult airway (history of difficult airway, mouth opening
Trial locations and contacts
No sites are listed yet.
About this study
( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries )
Read the detailed description
ketofol, which is a combination of ketamine and propofol, has been increasingly used because the advantages and disadvantages of propofol and ketamine complement each other and increase their effectiveness. Recently, the use of a combination of ketamine and propofol (ketofol) as a sedative has been attracting attention in various clinical fields. Theoretically, the combination of ketamine and propofol can reduce the dose of each drug and compensate for the disadvantages of the other through the antagonistic characteristics of both drugs, resulting in beneficial results for successful sedation
. Most of the time propofol and ketamine have been used as an induction agent in adult surgical patients but propofol may cause cardiorespiratory depression while ketamine increases heart rate and arterial blood pressure. On the other hand, the clinical effects of propofol and ketamine seem to be complementary. Ketofol is most commonly used for procedural sedation hence exploring its effectiveness for induction will be paramount for the clinical care of surgical patients Inhalation anesthetics (nitrous oxide, halothane, isoflurane, desflurane, sevoflurane, most commonly used agents in practice today) are used for induction and maintenance of general anesthesia in the operating room. The volatile anesthetics (halothane, isoflurane, desflurane, and sevoflurane) are liquids at room temperature and require the use of vaporizers for inhalational administration. Nitrous Oxide is already under normal conditions of temperature and pressure. All inhalational anesthetics provide amnesia and immobility, except for nitrous oxide, which also provides analgesia. Inhaled anesthetics are commonly used in combination with IV anesthetic agents. These agents have FDA approval for use as a general anesthetic and sedation agent in the operating room. Inhaled anesthetic agents have also had use in the intensive care unit, but this is not an FDA-approved indication. The primary applications of inhaled anesthetic agents in the ICU are sedation, refractory bronchospasm, and control of status epilepticus unresponsive to anticonvulsant medications.
- Conditions
- Abdominal Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The sample will be randomly assigned into one of two equal groups ((Group-I (n | Sample size calculation was carried out using G*Power 3 software (Faul et al., 2007)1 calculated minimum sample of 80 patient candidate for cancer surgery will be needed. The sample will be randomly assigned into one of two equal groups ((Group-I (n=40): will receive standard general anesthesia as control, and Group III (n=40): will receive Ketofol in addition to the standard general anesthesia. The calculated sample will be needed to detect an effect size of 0.1 in the RM-ANOVA (within group-between groups and interaction) on repeated measurements (every 2-hours postoperatively) for the mean VAS score, with an error probability of 0.05 and 95% power. |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
pain according to VAS score
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Hussein Khalefa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265948
- Sponsor's protocol ID
- comparsion drugs in cancer
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia
- ClinicalTrials.gov ID
- NCT06265948
- Acronym / sponsor ID
- comparsion drugs in cancer
- Conditions
- Abdominal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 20 Feb 2024 (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.
( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries )
Detailed description
ketofol, which is a combination of ketamine and propofol, has been increasingly used because the advantages and disadvantages of propofol and ketamine complement each other and increase their effectiveness. Recently, the use of a combination of ketamine and propofol (ketofol) as a sedative has been attracting attention in various clinical fields. Theoretically, the combination of ketamine and propofol can reduce the dose of each drug and compensate for the disadvantages of the other through the antagonistic characteristics of both drugs, resulting in beneficial results for successful sedation
. Most of the time propofol and ketamine have been used as an induction agent in adult surgical patients but propofol may cause cardiorespiratory depression while ketamine increases heart rate and arterial blood pressure. On the other hand, the clinical effects of propofol and ketamine seem to be complementary. Ketofol is most commonly used for procedural sedation hence exploring its effectiveness for induction will be paramount for the clinical care of surgical patients Inhalation anesthetics (nitrous oxide, halothane, isoflurane, desflurane, sevoflurane, most commonly used agents in practice today) are used for induction and maintenance of general anesthesia in the operating room. The volatile anesthetics (halothane, isoflurane, desflurane, and sevoflurane) are liquids at room temperature and require the use of vaporizers for inhalational administration. Nitrous Oxide is already under normal conditions of temperature and pressure. All inhalational anesthetics provide amnesia and immobility, except for nitrous oxide, which also provides analgesia. Inhaled anesthetics are commonly used in combination with IV anesthetic agents. These agents have FDA approval for use as a general anesthetic and sedation agent in the operating room. Inhaled anesthetic agents have also had use in the intensive care unit, but this is not an FDA-approved indication. The primary applications of inhaled anesthetic agents in the ICU are sedation, refractory bronchospasm, and control of status epilepticus unresponsive to anticonvulsant medications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The sample will be randomly assigned into one of two equal groups ((Group-I (n | – | –Sample size calculation was carried out using G*Power 3 software (Faul et al., 2007)1 calculated minimum sample of 80 patient candidate for cancer surgery will be needed. The sample will be randomly assigned into one of two equal groups ((Group-I (n=40): will receive standard general anesthesia as control, and Group III (n=40): will receive Ketofol in addition to the standard general anesthesia. The calculated sample will be needed to detect an effect size of 0.1 in the RM-ANOVA (within group-between groups and interaction) on repeated measurements (every 2-hours postoperatively) for the mean VAS score, with an error probability of 0.05 and 95% power. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion Criteria: * a. Inclusion criteria: 1. Age group 18 - 60 years old. 2. Both gender 3. ASA 1and 2 Exclusion Criteria: * a. Inclusion criteria: 1. Age group 18 - 60 years old. 2. Both gender 3. ASA 1and 2 b. Exclusion criteria: <!-- --> 1. Patient refusal, 2. History of cardiac or respiratory disease, psychological disorders, 3. High risk of regurgitation or aspiration based on a history of diabetes, hiatus hernia, gastroesophageal reflux, and obesity, 4. neck pathology, 5. Predicted difficult airway (history of difficult airway, mouth opening
Key inclusion criteria (4 listed)
- a. Inclusion criteria:
Key exclusion criteria (11 listed)
- a. Inclusion criteria:
- <!-- -->
- hiatus hernia, gastroesophageal reflux, and obesity,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
post operative pain
Time frame: two hours
pain according to VAS score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Cancer, run by Assiut University.
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 11 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 khaled Hussien (01029314432, kh1357kha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain (time frame: two 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 20 Feb 2024.