Dexmedetomidine and Laparoscopic Surgery

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03172065
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.3
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

Conventionally General anaesthesia remains the choice for the majority of open abdominal surgical procedures, and regional anaesthesia is preferred only for patients who are at high risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the first choice for laparoscopic cases was its advantages over general anaesthesia which include uniform total muscle relaxation, a conscious patient, economical, relatively uneventful recovery, pain free early postoperative period and the protection from potential complications of general anaesthesia. The main debatable point, however, seems to be the status of respiratory parameters among the two modes of anaesthesia during laparoscopic surgery. In this context it can be stated that spontaneous physiological respiration during spinal anaesthesia would always be better than an assisted respiration as in general anaesthesia.

The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Complication	Drug: Normal saline; Drug: Dexmedetomidine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: The Effect of Adding Intrathecal Dexmedetomidine on Shoulder Tip Pain During Laparoscopic Ovarian Cystectomy Under Bupivacaine Spinal Anaesthesia. Randomised Controlled Study.
• Actual Study Start Date: Jul 1, 2017
• Actual Primary Completion Date: Jul 5, 2018
• Actual Study Completion Date: Jul 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: control group will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml saline	Drug: Normal saline; intravenous flluid
Other: Dexmedetomidine group will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml dexmedetomidine (0.5 mic)	Drug: Dexmedetomidine; anaesthetic adjuvants and pain killer medication.

Outcome Measures

Primary Outcome Measures

1. occurrence shoulder tip pain [48 hours]

Secondary Outcome Measures

1. intraoperative haemodynamic stability, et co2, sao2. [2 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective gynaecological laparoscopic surgery

• Age 20-45 yrs

• Suspected surgery time 30 minutes

• Inflation pressure <13 Cm H20

Exclusion Criteria:

• Contraindications to regional block (infection at the needle insertion site)

• Altered conscious level.

• Pregnancy

• Body mass index >35

• Height <155 cm

• Patients who have difficulty understanding the study protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rasha Hamed, Lecturer of anesthesia, Assiut University
• ClinicalTrials.gov Identifier: NCT03172065
• Other Study ID Numbers: IDGL
• First Posted: Jun 1, 2017
• Last Update Posted: Aug 21, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dexmedetomidine

Study Results

No Results Posted as of Aug 21, 2020