Comparison of Intrathecal Dexmedetomidine and Fentanyl on Vital parameters, stress response and Post-operative pain in Laparoscopic cholecystecomy surgeries.

Phase 1

Not yet recruiting

• Conditions: Malignant neoplasm of intestinal tract, part unspecified,

• Registration Number: CTRI/2018/10/016016
• Lead Sponsor: Nizams Institute of Medical Sciences

Brief Summary

This study is a randomized double blind clinical investigation planned to evaluate effect of intrathecal Fentanyl and Dexmedetomidine on the hemodynamic stress response and postoperative analgesia when compared to a placebo control group.A total of 75 ASA Grade 1 and Grade 2 Patients will be enrolled after written informed consent and assigned to 25 to each group in a computerized randomly generated no.Baseline vitals noted in each of these patients. Intra-thecal Fentanyl 50mcg or Dexmedetomidine 10mcg or equal volume of sterile saline will be given under aseptic precaution in their respective allocated group. All the patients will be induced with Inj.Propofol 2mg/kg, Inj.Fentanyl 2mcg/kg and Inj.Atracurium 0.5mg/kg, and Sevoflurane after Pre-oxygenation for 3 minutes and Intubation to be done with adequate sized tube. All the patients will be given 30mg of Inj Ketorolac in 100 ml of NS slow Iv Infusion completed before incision.Anesthesia will be maintained with sevoflurane, ventilation  with oxygen and air, intermittent use of Inj Atracurium. Sevoflurane will be titrated to maintain MAP around 20% of baseline, else short bolus of Inj Nitroglycine will be given IV. After Completion of surgery neuromuscular blockade reversal to be done with Inj Neostigmine 50mcg/kg, Inj Glycopyrrolate 10mcg/kg. Vitals In all phases of pneumoperitoneum will be noted. Recovery time from anesthesia will be noted by calculating time from stopping inhalation agents to extubation. VAS score calculated, any score more than 4 will be given with rescue analgesia with Inj Paracetamol 1mg/kg slow IV infusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-15
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• A total of 75 patients of ASA GI and ASA GII divided in to three groups of 25 each in Group 1 ,2 and 3 and Intrathecal Dexmedetomidine 10mcg, Fentanyl 5omcg and equal volume of Normal saline used in three groups respectively.
• The response is noted in different stages of surgery like pneumo-peritoneum creation, deflation, recovery and post-operative analgesia.

Exclusion Criteria

Coagulation abnormality Infection at the site of Injection Emergency surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemodynamic stress response to pneumo-peritoneum	At the end of surgery.

Secondary Outcome Measures

Name	Time	Method
Postoperative analgesia	Upto 24 hours after end of surgery

Trial Locations

Locations (1)

Nizams Institute of Medical Sciences; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Nizams Institute of Medical Sciences

🇮🇳Hyderabad, ANDHRA PRADESH, India

JNirmala

Principal investigator

9849422749

njonnavithula@gmail.com