Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity

Sponsor

Assiut University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03024957

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

this work aims to investigate the effect of intrathecal administration of Morphine, Dexmedetomidine or both in combination on cellular immunity and cytokine production in patients undergoing major abdominal cancer surgeries.

Condition or Disease	Intervention/Treatment	Phase
Immune System Suppression	Drug: Morphine Sulfate Drug: Dexmedetomidine Drug: Bupivacaine	Phase 1/Phase 2

Detailed Description

Intrathecal (IT) adjuvants prolong the duration of spinal anesthesia and postoperative analgesia thereby reducing the requirement of postoperative supplemental analgesics. The incorporation of adjuvants also lowers the overall dose of local anesthetic and hence associated side effects. Morphine has been used widely to alleviate various types of pain and to supplement general anesthesia. On the other hand, morphine has been reported to possess some immunosuppressive effects. Postoperative immunity is also important in conjunction with defence against malignant tumour. Dexmedetomidine is a highly selective α2 agonist with analgesia, sedation, anxiolysis, and sympatholysis as its useful pharmacological actions. The extended analgesic efficacy of IT dexmedetomidine (ITD) in the postoperative period has been shown in a few clinical studies. In addition, current insights have identified that dexmedetomidine has a capacity in inhibiting the overproduction of a variety of inflammatory molecules including TNF-α, IL-1β, and IL-6 in several acute inflammatory animal models.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity in Patients Undergoing Major Abdominal Cancer Surgeries

Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexmedetomidine group patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine in 1 mL volume intrathecally.	Drug: Dexmedetomidine Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces. Drug: Bupivacaine Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.
Active Comparator: Morphine group patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 0.5 mg morphine sulphate in 1 mL volume intrathecally.	Drug: Morphine Sulfate Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces with injection of morphine sulphate . Drug: Bupivacaine Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.
Active Comparator: Dexmedetomidine + morphine group patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine plus 0.5 mg of morphine sulphate in 1 mL volume intrathecally.	Drug: Morphine Sulfate Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces with injection of morphine sulphate . Drug: Dexmedetomidine Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces. Drug: Bupivacaine Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.

Arm

Intervention/Treatment

Active Comparator: Dexmedetomidine group

patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine in 1 mL volume intrathecally.

Drug: Dexmedetomidine