Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia

NCT ID: NCT06265948

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2025-05-31

Brief Summary

( 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.

Conditions

Abdominal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age group 18 - 60 years old.

2. Both gender

3. ASA 1and 2

1. Age group 18 - 60 years old.

2. Both gender

Exclusion Criteria

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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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Khaled Hussein Khalefa

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

khaled Hussien

Role: CONTACT

kh1357kha@gmail.com

01029314432

Essam Manaa

Role: CONTACT

essam.manaa@med.au.edu.eg

‪+20 102 446 6633‬

Other Identifiers

comparsion drugs in cancer

Identifier Type: -

Identifier Source: org_study_id