NCT03024957

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

January 11, 2017

Last Update Submit

January 13, 2021

Conditions

Immune System Suppression

Keywords

morphinedexmedetomidineimmune system

Outcome Measures

Primary Outcomes (1)

  • Change from the base line in cellular immunity

    CD3, CD4, CD4/CD8, CD16, CD56

    Baseline , immediate postoperative, 4 hours postoperative and 24 hours postoperative

Secondary Outcomes (1)

  • Change from baseline in Cytokines

    Baseline, immediate postoperative, 4 hours postoperative and 24 hours postoperative

Study Arms (3)

Dexmedetomidine group

ACTIVE COMPARATOR

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

Drug: DexmedetomidineDrug: Bupivacaine

Morphine group

ACTIVE COMPARATOR

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 SulfateDrug: Bupivacaine

Dexmedetomidine + morphine group

ACTIVE COMPARATOR

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 SulfateDrug: DexmedetomidineDrug: Bupivacaine

Interventions

Morphine SulfateDRUG

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 .

Dexmedetomidine + morphine groupMorphine group
DexmedetomidineDRUG

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.

Dexmedetomidine + morphine groupDexmedetomidine group
BupivacaineDRUG

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.

Dexmedetomidine + morphine groupDexmedetomidine groupMorphine group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II patients scheduled for major abdominal cancer surgeries

You may not qualify if:

  • patients with known allergy to the study drugs,
  • significant cardiac, respiratory, renal or hepatic disease,
  • drug or alcohol abuse,
  • psychiatric illness that would interfere with perception and assessment of pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 171516, Egypt

Location

MeSH Terms

Interventions

MorphineDexmedetomidineBupivacaine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia, ICU and pain managment

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 19, 2017

Study Start

January 1, 2017

Primary Completion

September 1, 2018

Study Completion

February 1, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)