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

( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries )

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Cancer

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: khaled Hussien; Phone Number: 01029314432; Email: kh1357kha@gmail.com
• Study Contact Backup: Name: Essam Manaa; Phone Number: ‪+20 102 446 6633‬; Email: essam.manaa@med.au.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	pain according to VAS score	two hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 11, 2024
• First Submitted That Met QC Criteria: February 11, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms
• Other Study ID Numbers: comparsion drugs in cancer

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No